Case Study

ISO 13485 Company and Device Certification

A Clearer Vision of Quality

Critical Software was approached by a state-of-the-art ophthalmology company to certify their medical device development processes according to ISO 9001:2008 and ISO 13485. Our work started off with a gap analysis of the client’s Quality Management System (QMS) before we implemented due processes and helped creating all the necessary support documentation.

In the end, we’ve ensured the client’s QMS was fully certified to all relevant standards, which increased the trustworthiness of development, and V&V processes.

Learn more about:

  • Every detail that our solution involved and how we approached the challenge.
  • Which standards and directives were considered in the process.
  • The resources and activities we used and performed.
  • How our solution provided the client with a sturdy and reliable QMS.
iso 13485 company and device certification case study