Case Study

Producing Certification Evidence for Medical Device Tools

Making sure everything is up-to-scratch is key in the medical devices industry, be it the devices themselves or the quality management systems keeping businesses in the sector going.

Yet this is sometimes easier said than done. Critical was tasked with producing certification evidence for the quality management systems used by an optical health device manufacturer. This included the definition of a testing strategy, test case specification, and test procedures which had to comply with FDA regulations.  

Critical’s work, producing recommendations on where the systems needed to be improved to achieve certification, meant the manufacturer could enjoy peace of mind when using these systems within the context of the medical devices industry. 

In this case study, learn about: 

  • The importance of quality management systems compliance with industry guidelines
  • How outsourcing certification evidencing can helpfully fill internal knowledge gaps
  • The test specification and procedure definition needed to carry out certification evidencing
  • The additional benefits of ensuring internal systems are compliant with regulations
Producing Certification Evidence for Medical Device Tools