Access over 7500 medical device standards and regulations with Compliance Navigator
- 7500+ medical device standards and regulations
- Advanced warning of standards and regulatory changes through in-product notifications and direct emails
- Gap analysis and expert commentary written by industry leaders
- Quickly find and access relevant documents using our intuitive search function
- Unlimited user access with each license for seamless collaboration across teams
Comprehensive, cost effective medical device compliance
From artificial intelligence to labelling and packaging standards and guidance, BSI Compliance Navigator transforms how medical device and IVD device manufacturers manage their regulatory documents to save time, maximise resources and reduce risk. Access regulations, internationally recognized standards, and guidance documents to support market access and continuous compliance for UK, EU and MDSAP countries.
Gain access to thousands of essential standards and regulations, including BSI, ASTM, CLSI, AAMI and more. Find out more by viewing our brochure today:
Access our free expertise today, including medical device webinars, white papers and blogs
Our latest webinar “Why standards are the best way to demonstrate conformity to regulations” by Lena Cordie-Bancroft, Sector Lead - Medical Devices, BSI, is now available for you to watch.
Understand regulatory and technological changes with our white papers, gain insight and access a range of expertise across medical devices sub sectors and topics:
EU MDR
- Implementing the European Union Medical Devices Regulations
- Person responsible for regulatory compliance (PRRC) - MDR/IVDR Article 15
EU IVDR
- How to best implement the EU IVDR – dos and don’ts
- Developing and maintaining a quality management system for IVDs
AIaMD and SaMD
Standards
- Using Standards to Demonstrate Conformity
- The Differences and Similarities between ISO 9001:2015 and ISO 13485:2016
We offer a comprehensive suite of medical device articles to ensure your questions are answered. Take a look below at a range of our latest content, written by industry professionals and standards developers.
