CE MARKING

Looking for ISO 13485 Certification in Messica? We help organisations across Manica plan, implement and certify ISO 13485, with consultants who understand how businesses in Messica work.

About ISO 13485 in Messica

The quality standard for organisations that design, manufacture or supply medical devices.

What organisations in Messica gain

  • Access to regulated medical markets
  • Risk-based design and production control
  • Ready for regulatory inspection

How we get you certified in Messica

  1. Discovery call. We learn how your organisation in Messica works and what the certificate needs to achieve for you.
  2. Gap analysis. We compare your current practices against ISO 13485 and agree the scope.
  3. Build and embed. We write proportionate documentation with your team and train the people who will run it.
  4. Audit and beyond. We run internal audits, support you through certification and help you keep improving.