Our coverage of medical devices in C2P provides 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.
The medical device landscape is undergoing significant changes, and staying on top of these evolving regulations is of critical importance. Our coverage of medical devices ensures that the medical devices you bring to market are safe and compliant.
Our medical device topic covers:
- Definition of medical devices
- Classification of medical devices
- Safety & efficacy / performance requirements
- Conformity assessment procedures
- Technical documentation
- Labeling and packaging
- Testing (clinical trial and evaluation)
- Provision of product information
- Record keeping
- Mandatory Unique Device Identification (UDI) mechanisms
- Quality Management Systems
- Requirements for qualified persons
- Post-market surveillance and consumer protection
Learn more about our Regulatory Coverage
Speak to one of our team today for more information on our regulatory content.