The long awaited text of the new MDR and IVDR brings with it more scrutiny of technical documentation; it addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and requiring better traceability of devices through the supply chain.
Are you prepared for the transition to the new Regulations? Are your products compliant?
Understand the regulatory requirements and manage your medical device compliance with BSI Compliance Navigator.
Request a demo today and see for yourself how Compliance Navigator can accelerate your business.