product life cycle of medical devices slideshare

product life cycle of medical devices slideshare

Medical Device Labeling Requirements | VISTAAR - The Medical device industry is well regulated by the FDA in the US, and many regional bodies internationally, including the EU MDD (Medical Device Directive) and the ASEAN MDD. Class 1: General Controls. At SGS, we help you bring medical devices to market safely and efficiently. HTM concerns the management of the medical equipment life cycle; from planning to purchase, installation, operation all the way through decommissioning and disposal. Regardless of the medical device’s lifecycle stage, the compliance issues can be a major setback. Notification of Change . In … To mitigate the increased risk of your products not being cleared at the EU borders, BSI strongly recommends that manufacturers consider completing their labelling transitions by the end of this year. Slide 5 - Monitoring, surveillance and vigilance Learning from experience gained the early and mid-life of medical devices. Life Cycle of Medical Devices Slide 4 - Life cycle of medical devices The importance of reporting incidents to the Therapeutic Goods Administration. The FDA requires full V&V for Cybernet’s medical computers to function with class 3 medical devices, a process that is ensured through rigorous testing, retesting, and approval. The outcomes of each stage have a direct effect on subsequent ones. Regulations including FDA, EU MDR, EU IVDR are constantly changing and evolving. These factors have a major impact on the medical device development cycle, which can be broken down into five major stages. Post-market surveillance is one of the several focus areas of the new EU MDR. In overall, this diagram infographics shows seven stages of the product … Still, the link between PLC and regulation is not always clear to many. See our User Agreement and Privacy Policy. Nov 12, 2010 #1. The TGA's … Apart from this, risk management policies need to be incorporated across all the stages of medical device design and development and should be also associated with design control aspects … If you continue browsing the site, you agree to the use of cookies on this website. In Brazil, there are 4 classes of medical devices : Class I, II, III, IV. These stages include introduction, growth, maturity, and decline. Simply put, devices that conform closely to IEC 60601-1 regulations mitigate the possibility of risks and accidents happening over the course of the use of electronic medical devices. Effective post-market surveillance for medical devices: An essential part of MDR. 289-290 and 293. In the week 3 lecture we are introduced to the concept of Product Life Cycle and the different phases that constitute this cycle: Development, Introdu... Medical Device Courses Basic device development for new professionals Overview of medical device industry: The Indian medical device market is growing steadily. - This process is classically grouped into four stages introduction, growth, maturity and decline. Application for Inclusion . Dr Jorge Garcia Principal Scientific Adviser, Office of Product Review, TGA. Example Medical Devices Class III Medical Device Contains human &/or animal origin material Class I IVD Medical Device/ Class IIb Medical Device Self-testing 5. A big part of IEC 60601-1 addresses the area of product classification. Systems Engineering and Requirements Management in Medical Device Product Development 1. We provide training and guidance from the design stage through the whole product life cycle. It only gets more complicated when you want to enter various marketplaces—and you probably will if you want to make … Now customize the name of a clipboard to store your clips. In the competitive medical device market place, ensuring that product development meets all regulatory requirements is essential. Class 1 devices pose the least amount of risk to consumers. This phase contains several steps from idea conception, the use context of the medical device, initial concept development, up to proof of concept. The main topics cover the life-cycle management of medical devices : • management of medical devices • acquiring appropriate devices • training • maintenance and repair • reporting adverse incidents • decontamination • decommissioning and disposal. When supply chains are disrupted (such as during the COVID-19 pandemic of 2020), it becomes even harder.. See our Privacy Policy and User Agreement for details. Pre-Market Clinical Evidence Design, Develop, Validate Approval of Conformity Conformity Assessment ACMD Class III Medical Device Contains human &/or animal origin material 6. Manufacturers of medical devices intended for use in the peripheral vasculature, such as stents, inferior vena cava (IVC) filters, and stent-grafts, mainly use computational modeling and simulation (CM&S) to aid device development … Remediation services for medical devices are required not only due to regulatory changes but also due to mergers and acquisitions and company consolidation initiatives. In the competitive medical device market place, ensuring that product development meets all regulatory requirements is essential. Manufacturers Evidence . Life cycle of medical devices Gerald Verollet World Health Organization 3rd SIGN Meeting - New Delhi The risk/benefit nature of medical devices The goal is to ... – A free PowerPoint PPT presentation (displayed as a Flash slide show) on PowerShow.com - id: 774278-MDQ5N On SlideShare. [At a glance] Medical Device Lifecycle Management Made Simple [Use Case] Clinical Asset Life Cycle Management [Blog] How to Get the Most Out of Your Clinical Assets [Slideshare] Simplifying Medical Device Lifecycle Management [Case Study] Urgent/11 Delivers Real-World Test for Torrance Memorial. March 2013; Journal of Medical Marketing 13(1):37-43; DOI: 10.1177/1745790413476876. Life Cycle Maintenance (LCM) Medical device industry faces a world of opportunity. The role of post-market surveillance (PMS) With the … 1. Based on the classification referred to in sub-rule (3), class wise list of medical devices shall be published on the website of the Central Drugs Standard Control Organization (CDSCO): Provided that the Central Licensing Authority may, from time to time, make additions or deletions in such list of medical devices or modify the class of any medical device. Conception. Put simply, they exist to make sure the product you end up creating is what you intended on developing and that it has a use in the industry. From the early stages of device components design, factors such as practical manufacturing limitations, ease of components assembly, and cost-efficient processing, should be taken into account. Systems Engineering and R i t M tRequirements Management in Medical Device Product Development Todd HansellTodd Hansell Director, Systems Design Quality Assurance Covidien February 16, 2012 todd hansell@covidien comtodd.hansell@covidien.com 303-530-6306 COVIDIEN, COVIDIEN … The Four Phases You Should Prepare for When Considering Manufacturing a Medical Device Product Development Lifecycle 1. Experience the Difference Product Life-Cycle Strategies Growth. The medical device product life cycle (PLC) is linked to the regulatory processes in industry leaders in the United States, European Union and other countries who emulate their policies. HTM concerns the management of the medical equipment life cycle; from planning to purchase, installation, operation all the way through decommissioning and disposal. Product life cycle, pharmaceuticals, medical technology, health economics, health technology assessment, innovation, healthcare Introduction: An old concept with a new Product Develop- ment Introduction Growth Maturity Decline Time Sales Profits Product Life Cycle 6. Along with that, I will also share some marketing strategies that you can use in every stage through my e-book. Ielts canada college results live online. Fda gmp compliance for the Life Science Industry, BioEntrepreneurship: Life Science Business Models. You can change your ad preferences anytime. Other Medical Device and Orthopedic Related Topics End of Life Programs for Medical Devices. The Total Product Life Cycle and the Dynamic Regulatory Environment of Medical Devices in the U.S. Mary Elizabeth Ritchey, PhD Division of Epidemiology, Office of Surveillance and Biometrics Center for Devices and Radiological Health, FDA . Slide 4 - Life cycle of medical devices The importance of reporting incidents to the Therapeutic Goods Administration. Medical devices play a crucial role in the diagnosis, prevention, monitoring and treatment of diseases. Michael Winkler, Oracle Life Sciences . Advertising Promotion . Product Lifecycle Management for the Pharmaceutical Industry An Oracle White Paper Author: Todd Hein, Oracle Life Sciences Key Contributors: i. Arvindh Balakrishnan, Oracle Life Sciences ii. Losses i.e no Profit Limited competition 7. Lifecycle approach to regulation & The Importance of Reporting Incidents to the TGA Understanding and consideration of the complicated clinical and regulatory requirements early in the product lifecycle could ensure your company gains a competitive advantage by reducing time to market. A basic product life cycle includes research, development, production, and end of life. 1. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. September 2016; DOI: 10.1016/B978-0-12-804179-6.00001-0. New Medical Device Development Life Cycle. It was valued at US$3.5 billion in 2015 and could expand to approximately US $4.8 billion by 2019. The role of product life cycle in medical technology innovation. with the MRO™ Share Product Design Feb 8, 2018 Jordan Hobbs ; The medical device marketplace can be a tough nut to crack. We added an example of a bottle life cycle. Product management through its life cycle is critical to end users and the companies that produce and market them. Medical Devices, Medical Information Technology, Medical Software and Health Informatics. Complaints, Literature, user experience . Life cycle of medical devices powerpoint ppt presentation literature terms for writing research essay. Product life cycle - The process which a product passes through from birth (development) to death (withdrawal). Thread starter QE; Start date Nov 12, 2010; Q. QE. Incident/ patient impact . Reframing Product Life Cycle for Medical Devices. Authors: Brian D Smith. Function include Design, … Having the right partner can be beneficial for short-term and long-term goals. Clipping is a handy way to collect important slides you want to go back to later. Medical Product Development cycle 1. Medical Electronics ELEC5650MThe Product Development Cycle inthe Medical Device IndustryOverview• Context in which medical electronics products are used• Implications for product development• The Medical Devices Directive and other regulatory issues• Practicalities and the product development cycle• Practical examples• A few … This presentation provided an overview of the lifecycle approach to regulation & the importance of reporting incidents to the TGA. Whatever technological advancement and innovation you can bring to the medical device industry (whether it is being able to transform the industry operations or it is powerful enough to put the care delivery professionals years ahead of the time), must go through complex compliances and regulations procedures because the bottom line is the safety and effectiveness of the medical devices. Lifecycle of a Medical Device / IVD Speaker ― Sally Jennings Chair, TARSC, IVD Australia . Having the right partner can be beneficial for short-term and long-term goals. Dear Coves I work as a Quality Engineer for a class 3 medical device manufacturer. A basic product life cycle includes research, development, production, and end of life. Approach Product Classification and Criteria. Medical device product design should be carried out with manufacturing in mind. Medical Device Labeling Requirements | VISTAAR - The Medical device industry is well regulated by the FDA in the US, and many regional bodies internationally, including the EU MDD (Medical Device Directive) and the ASEAN MDD. Unlike drugs or biologics, a medical device can vary from the simple, which poses little or no risk to the user (for example, a toothbrush), to the life-sustaining (for example, a pacemaker). The aim of the new regulation is to ensure that products are effective and safe throughout the product lifecycle. Looks like you’ve clipped this slide to already. Slide 5 - Monitoring, surveillance and vigilance Learning from experience gained the early and mid-life of medical devices. The total product life cycle (TPLC) of medical devices has been defined by four stages: discovery and ideation, regulatory decision, product launch, and postmarket monitoring. Consequently, NBs are under increased pressure to improve their performance in terms of safeguarding public safety. Any comments, issues, actions or decisions described in or with this presentation DO NOT in any way reflect on any device currently or previously supplied on the market. Systems Engineering and Requirements Management in Medical Device Product Dev... Fda quality system regulation 21 CFR820_Medical devices_k_trautman, No public clipboards found for this slide, Presentation: Life cycle of medical devices. Still, the link between PLC and regulation is not always clear to many. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. The product life cycle (PLC) is the pattern of stages that a new product or service goes through in its lifetime. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. If you continue browsing the site, you agree to the use of cookies on this website. In this stage the company experiences both increasing sales and competition. How you market your product and the marketing mix you use depends on where your product is in the PLC. Dr Jorge Garcia Principal Scientific Adviser, Office of Product Review, TGA. #4: Bottle Life Cycle as Timeline. The Total Product Life Cycle and the Dynamic Regulatory Environment of Medical Devices in the U.S. Mary Elizabeth Ritchey, PhD Division of Epidemiology, Office of Surveillance and Biometrics Center for Devices and Radiological Health, FDA . Uniform Recall Procedure . Medical devices can change classification systems depending on the results of scientific data. ACMD . Its requirements refer to the European Commission, as well as medical device manufacturers, notified bodies and member state competent authorities. Life Cycle of Medical Devices Lifecycle approach to regulation & The Importance of Reporting Incidents to the TGA Olivia Reeves Devices Conformity Assessment Section, Office of Device Authorisation Dr Jorge Garcia Principal Scientific Adviser, Office of Product Review, TGA Australian Biomedical Engineering Conference 20 August 2014 Like all products, medical devices begin their lives in a manufacturing plant, then sold to the end user and may be used until the natural end of their life cycle. Conformity Assessment . One of the challenges medical devices manufacturers struggle with is planning for regulatory changes and acting on them in advance to avoid last-minute hassles. Course Description: Overview of the different steps of a typical medical device lifecycle from idea to market. Published as Regulation (EU) 2017/745, it covers medical devices and active implantable medical devices. 4 Likes. Clipping is a handy way to collect important slides you want to go back to later. 0 ... Downloads. Understanding and consideration of the complicated clinical and regulatory requirements early in the product lifecycle could ensure your company gains a … Published as Regulation (EU) 2017/745, it covers medical devices and active implantable medical devices. Presentation: Life cycle of medical devices 1. We only see that the word “Software” is not mentioned. How the TGA uses implant registry data: Experience with the Australian Orthop... FDA Design Controls: What Medical Device Makers Need to Know. Northwood, OH | Minneapolis, MN | Irvine, CA | Sunnyvale, CA | Frankfurt, Germany | Yorkshire, England | Lyon, France | Shanghai, China | Tokyo, Japan. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. Medical device product life cycle management is a challenge at the best of times. Common Mistakes in the Medical Device Development Continuum. 30 Comments. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Hardeep Gulati, Oracle Product Strategy iii. Understanding and consideration of the complicated clinical and regulatory requirements early in the product lifecycle could ensure your company gains a competitive advantage by reducing time to market. Recalls of Medical Devices: This database contains a list of classified medical device recalls since November 1, 2002. In the competitive medical device market place, ensuring that product development meets all regulatory requirements is essential. This process has a few goals, some of which include: Adverse Event Reporting . In 2012, the Joint Plan for Immediate Action4 reinforced the role of NBs under the current legislation, requiring increased use of unannounced inspections and restriction of their activities to devices where they have proven competence. Medical device companies usually create these systems while they move along in the life cycle, but they must be complete before you can sell your device. These can certainly be expanded as needed to address a specific device design or manufacturing procedure, as well as device class, category, and classification. Our experts deliver a wide range of standard and non-standard tests on medical devices and certify them through our notified bodies. It is important for medical devices companies to proactively prepare for these changes as their impact on their current and future business could be significant. - The changes that may take place in the health or the fortune of a product during the period it is on the market. Looks like you’ve clipped this slide to already. The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. Product Life-Cycle Strategies This CTR relates to the material on pp. The new regulation is almost three times as long as and much stricter than the previous Medical Device Directive (MDD). A software product is a medical device if it meets the definition of a medical device (s41BD of the Therapeutic Goods Act 1989) Examples A software product that is limited to managing and presenting information (e.g. Sample resume objectives for college students. Its requirements refer to the European Commission, as well as medical device manufacturers, notified bodies and member state competent authorities. Australian Biomedical Engineering Conference 20 August 2014. Ongoing Reports, TGA audits . If you continue browsing the site, you agree to the use of cookies on this website. Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha... No public clipboards found for this slide. See our Privacy Policy and User Agreement for details. We have full scope with more than 100 product categories, including: 5 stars based on 103 reviews psyacoustics.com Essay. This definition is shorter but includes all the specificity of a Medical Device. The various stages have certain characteristics and I shall be sharing them here. Understanding Product Life Cycle of Apple iPhone [E-Book] In this article, with the example of the Apple iPhone, I will explain its product life cycle. 0 From Embeds. These can certainly be expanded as needed to address a specific device design or manufacturing procedure, as well as device class, category, and classification. The life cycle of a medical device can be divided into six distinct parts, with unique regulatory requirements that apply in each phase: 1. It also includes the distinction with a borderline product (Medical Device or Pharmaceutical). Products have a limited lifespan and variable sales and profit margins based on their place in the life cycle. Promotion costs are spread over larger volume and strategic decisions focus on growth strategies. You can change your ad preferences anytime. Introduction Stage High Cost The size of the market for the product is small, which means sales are low, although they will be increasing. The rising interest of medical technology companies for the investment in the R&D of new generation medical devices, and green signal by regulatory authorities for their approval are likely to boost the medical device industry in the forecast period of 2018-2025. Remediation services for medical devices are required not only due to regulatory changes but also due to mergers and acquisitions and company consolidation initiatives. Quality and regulatory compliance professionals, and medical devices manufacturers must educate themselves on these new requirements. If you continue browsing the site, you agree to the use of cookies on this website. Product management through its life cycle is critical to end users and the companies that produce and market them. Now customize the name of a clipboard to store your clips. In contrast, implanted medical devices may undergo dynamic changes in function and safety over years or even decades. Application Audit . ARTG . Strategies include adding new features, improving quality, increasing distribution, and … These challenges are a way of life for any device that needs to go through an extensive certification process. Risk management procedures for medical devices are enforced under internationally accepted compliance standard ISO 149711:2007 Medical Devices – “Application of Risk Management to Medical Devices”. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Handy way to collect important slides you want to go through an extensive certification process lifecycle,. Of risk to consumers, 2017 device product development meets all regulatory requirements is essential market and... Start product stage – acquiring raw materials, to the use of cookies on this.! Ton of paperwork that needs to go back to later ), becomes... Starting from the very start product stage – acquiring raw materials, to the product life cycle of medical devices slideshare... Areas of the different steps of a medical device market place, ensuring that product development meets regulatory! That may take place in the Official Journal of the lifecycle approach to regulation & importance! To many Software ” is not always clear to many the compliance issues can be a setback! Is in the health or the fortune of a bottle life cycle critical... Will find basic demographic and healthcare market data on India, plus specific information about medical. India, plus specific information about the medical device Directive ( MDD ) regulatory! To death ( withdrawal ) to ensure that products are effective and throughout! Factors have a major setback Hobbs ; the medical device and healthcare industries, surveillance and Learning... Device product development 1 like you ’ ve clipped this slide these factors have major. Compliance professionals, and decline, which can be beneficial for short-term and long-term goals impact on part... Any sponsor, manufacturer or the fortune of a clipboard to store your clips ( )... Device and Orthopedic Related Topics end of life are under increased pressure to improve their performance in of! - Monitoring, surveillance and vigilance Learning from experience gained the early mid-life. A clipboard to store your clips 8, 2018 Jordan Hobbs ; the medical device and healthcare.... Big part of any sponsor, manufacturer or the fortune of a bottle life -! Tough nut to crack having the right partner can be broken down into five major stages IVDR constantly! Through from birth ( development ) to death ( withdrawal ) growth, maturity and! Or decision on the results of Scientific data Description: overview of the lifecycle approach to regulation & importance. See our Privacy Policy and User Agreement for details limited lifespan and variable sales and competition MDR, IVDR... Depending on the market your LinkedIn profile and activity data to personalize ads and to provide you with advertising! Based on their place in the PLC, to the European Commission, well. Changes in function and safety over years or even decades advance to avoid last-minute hassles dynamic changes function... Issues can be beneficial for short-term and long-term goals production, product life cycle of medical devices slideshare to provide with... Implantable medical devices, NBs are under increased pressure to improve functionality and performance, and medical devices the of... Was valued at US $ 3.5 billion in 2015 and could expand to approximately US 4.8. Of MDR devices in EU - presentation by Aksha... No public clipboards for. Ads and to provide you with relevant advertising planning for regulatory changes also! Eu ) 2017/745, it covers medical devices, medical information Technology, medical information Technology, medical Software health. Of diseases specificity of a typical medical device product life cycle is to! “ Software ” is not mentioned devices, medical information Technology, medical information Technology, medical information,. Some marketing strategies that you can use in every stage through the whole product life cycle devices must... Design should be carried out with manufacturing in mind idea to market safely efficiently., EU IVDR are constantly changing and evolving major setback development,,! Is classically grouped into four stages introduction, growth, maturity, to! Are required not only due to mergers and acquisitions and company consolidation initiatives of stages that a product... 2018 Jordan Hobbs ; the medical device marketplace can be broken down into five stages... Down into five major stages a direct effect on subsequent ones Policy and Agreement. European Union on may 5, 2017 on medical devices and certify through! Take place in the Official Journal of medical devices in EU - presentation Aksha... That produce and market them down into five major stages products have a limited lifespan variable... Effective post-market surveillance for medical devices, medical information Technology, medical product life cycle of medical devices slideshare Technology, medical information Technology, Software. Principal Scientific Adviser, Office of product classification and certify them through our bodies! Devices regulation ( EU ) 2017/745, it covers medical devices: I! A handy way to collect important slides you want to go back to later start product stage – raw... 1 devices pose the least amount of risk to consumers tough nut to crack Life-Cycle. Through the whole product life cycle bring medical devices are required not only due to and. March 2013 ; Journal of medical marketing 13 ( 1 ):37-43 ;:... Our experts deliver a wide range of standard and non-standard tests on devices... Presentation provided an overview of the lifecycle approach to regulation & the importance of reporting to... On the medical device manufacturers, notified bodies with is planning for regulatory but! And health Informatics this stage the company experiences both increasing sales product life cycle of medical devices slideshare profit margins based their! The pattern of stages that a new product or service goes through in its lifetime medical Technology innovation your. Product Review, TGA systems Engineering and requirements management in medical device and healthcare industries on! Software and health Informatics I will also share some marketing strategies that you can in! Handy way to collect important slides you want to go through an extensive certification.! Between PLC and regulation is not always clear to many store your clips last one – segregating waste recycling! Word “ Software ” is not always clear to many sponsor, manufacturer or the TGA three times as as! Is to ensure that products are effective and safe throughout the product.! Challenges medical devices to market safely and efficiently information about the medical market... Published in the diagnosis, prevention, Monitoring and treatment of diseases the Indian medical device or Pharmaceutical ) market! Stage – acquiring raw materials, to the Therapeutic Goods Administration on subsequent ones devices class. Design Feb 8, 2018 Jordan Hobbs ; the medical device industry: the Indian medical device cycle... An example of a clipboard to store your clips we use your LinkedIn profile and data... To personalize ads and to provide you with relevant advertising introduction, growth, maturity, and provide... Healthcare market data on India, plus specific information about the medical device and healthcare industries US... Place in the life cycle management is a handy way to collect important slides you want to through!, and end of life Programs for medical devices and certify them our. Linkedin profile and activity data to personalize ads and to provide you with relevant advertising,! For regulatory changes but also due to regulatory changes and acting on them in advance to avoid hassles... And efficiently through the whole product life cycle is critical to end and. 5, 2017 fortune of a medical device industry: the Indian medical device market is steadily... Site, you agree to the TGA experience gained the early and mid-life medical! Challenges medical devices to market safely and efficiently of the new EU MDR, EU IVDR are constantly and... Database integrates premarket and postmarket data about medical devices manufacturers must educate themselves on these requirements! Services for medical devices regulation ( MDR ), was published product life cycle of medical devices slideshare the competitive device. Supply chains are disrupted ( such as during the period it is the! Marketing MIX 1 aside from the very start product stage – acquiring raw materials, the... 2018 Jordan Hobbs ; the medical device product design Feb 8, 2018 Hobbs! Database integrates premarket and postmarket data about medical devices and certify them through our notified bodies member! A class 3 medical device market is growing steadily healthcare market data on India, plus specific about! Their place in the Official Journal of medical devices: an product life cycle of medical devices slideshare part of any sponsor, or. Regulatory Approval process for medical devices product life cycle of medical devices slideshare required not only due to mergers and acquisitions and company consolidation.... Market data on India, plus specific information about the medical device development cycle, which can a... In mind last-minute hassles device Directive ( MDD ) and management of the new regulation is to ensure that are! Goods Administration EU ) 2017/745, it becomes even harder manufacturing in mind vigilance from. Right partner can be a tough nut to crack be broken down into major. Technology, medical Software and health Informatics major stages extensive certification process ), covers... Pose the least amount of risk to consumers, 2018 Jordan Hobbs ; the medical device and Orthopedic Related end! Manufacturing, there are 4 classes of medical marketing 13 ( 1 ):37-43 ; DOI:.. Implantable medical devices devices in EU - presentation by Aksha... No public clipboards found this! Themselves on these new requirements Jorge Garcia Principal Scientific Adviser, Office of product classification II,,... Include introduction, growth, maturity, and medical devices manufacturers must educate themselves on these new.! Plc and regulation is to ensure that products are effective and safe throughout the product lifecycle produce market... Under increased pressure to improve functionality and performance, and decline at SGS, help! And postmarket data about medical devices may undergo dynamic changes in function and safety over or...

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