QMS & ISO 13485

Implementation of the MDR or the IVDR is an extensive project and the road to it is paved with challenges. Putting it shortly, all companies are strongly advised to come up with a comprehensive transition plan. 

Although the deadline of May 2020 may seem far away, this is actually a false sense of security. To ensure continuous compliance of your products to the new legislation an early start, a thought-through plan, and management buy-in are necessary elements to a successful project.

Your QMS should cover:

  • Design

  • Manufacturing

  • Supplier management

  • Risk management complaint handling

  • Clinical data

  • Storage

  • Distribution

  • Product labeling