Medical Device Compliance Resources

Optimizing Your Path to Market-Ready Solutions

Access actionable tools like checklists, whitepapers, and survey insights tailored to support your regulatory compliance and innovation in medical device development.

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MTI Survey Report - Celegence

Medical Device Regulatory Survey Report 2024

Be the first to explore pivotal findings that will shape the future of MedTech regulation. Our survey covered key topics such as current challenges, resource allocation, advanced technologies, and regulatory processes to provide a clear picture of where the industry is headed.

EU MDR - Technical Documentation Checklist - Celegence

EU MDR Checklist

The checklist highlights all the key areas that you need to be aware of and serves as a guide to help get you compliant. In conjunction with this checklist we are also able to provide you with bespoke plans on how to get your business up to speed and are currently working with businesses from Canada, USA, India and throughout Europe ensuring that they are ready for the switch come later this year.

EU IVDR Checklist

EU IVDR Checklist

The checklist highlights all of the documentation that you will need in place for certification of your IVD device and will serve as a guide to help you achieve ongoing compliance.

Brexit Whitepaper - Celegence

The Burden of Brexit on the Medtech Industry: Whitepaper

Make sure your organization is well versed and prepared for the implications of Brexit by reading Celegence’s White Paper examining the challenges and implications of compliance in the United Kingdom following Brexit.