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.