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  • Medical Devices Product Compliance


    Achieve uninterrupted global market access for your Medical Device

    Compliance & Risks helps ensure that the medical devices you bring to market are safe & compliant by providing up-to-date global coverage of laws and regulations, proposed, enacted & amended, as well as relevant standards, guidance documents, factsheets and more impacting the placing on the market of medical devices, including IVDs.

     

    The medical device landscape is undergoing significant changes, with the COVID-19 pandemic resulting in new regulation across the globe, and Brexit creating a new set of obligations and challenges for medical device manufacturers. Additionally, as wearables and health trackers continue to grow in popularity, electronics manufacturers are finding themselves in a new position where their products can now be considered medical devices. Staying on top of these evolving regulations is of critical importance.

    Market Access & Compliance Knowledge Management platform


    Manage everything in one place with automated alerts, powerful search, and easy to use interface.

    Prove You are Compliant
    C2P tracks and monitors the evidence of your compliance to ensure that you are fully aware of any risk across your business and can easily access and produce the relevant evidence.

     

    Know What Evidence and Standards are Needed
    C2P’s requirements tool allows you to monitor the components of your product and set required criteria,  based on monitored regulations, standards, or internal benchmarks.

     

    Never Miss a Regulatory Update
    Regulations and standards within our system have been translated, summarised and classified for easy search and decision making.

     

    A Purpose Built Compliance Management Platform
    All the functionality you need. Including alerts for response to upcoming regulatory changes, refined to match your products of interest.

     

    World Leading Medical Device Regulatory Coverage


    Regulations & Standards & Product Requirements covering 226 geographic markets worldwide.

    Medical Device product categories covered including:

    • EClass for medical device
    • Anesthesia & Intensive Care Equipment
    • Diagnostic Equipment
    • Disability Care & Aids
    • Hospital Equipment

    And many more. Get in touch with us to check whether your product category is covered.

    Achieve uninterrupted market access in 226 geographic markets worldwide


    Our Global Regulatory Compliance Team is here to help.

    Market Access Reporting
    Successful access to new markets is key for any compliance function. Our Medical Devices content will give you complete access to every regulation relevant to the market, but if you would like us to go the extra mile, our expert team can create the Market Access reports on your behalf.

    Our experienced team of Market Access experts will be happy to support your Market Access needs. Our reports are relied on by many well known companies in the Medical Devices space. 

     

    Ask Our Experts
    All our clients receive access to our ‘Ask Our Experts’ function. Allowing you to ask questions of the market experts who compile our Medical Device content library. We can advise on the regulations, or even ask anonymized questions of the regulator on your behalf.

    Talk To Us

    Benefits


    Compliance & Risks combine technology, information and insights into knowledge to enable action.

    Design your medical devices to stay on the market longer

    Reduce time to market

    Identify new markets for which you are already compliant

    Reduce costs

    Reduce risk

    Webinar: Regulatory Developments in Medical Devices: Your Questions Answered


    In the wake of the COVID-19 pandemic, with new regulation in the EU and Asia, and Brexit in the UK, many manufacturers have questions about the implications of recent and forthcoming changes. In this webinar our expert panel discuss these developments and more.

    Watch On-Demand

    Suggested Resources


    White Paper: Medical Device Regulatory Developments in the EU, UK and China
     
    Compliance & Risks Launches Global Medical Device Regulatory Coverage
     
    Webinar: Regulatory Developments in Medical Devices: Your Questions Answered
     

    Would you like to better monitor and manage regulations, standards and requirements?