CE MARKING

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

About ISO 13485 in Vyaz’ma

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

What organisations in Vyaz’ma gain

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

How we get you certified in Vyaz’ma

  1. Discovery call. We learn how your organisation in Vyaz’ma 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.