Regulatory & Clinical

Regulatory and Clinical requirements for successful commercialization are getting increasingly complex by the day…

This is why we have robust infrastructure, such as:

  • FDA Registered Sites
  • OEM-level Quality Systems
  • Verification & Validation
  • Documentation Management

We are listed as the “contract manufacturer” where required by our OEM partners.

We have the knowledge and insight to guide new medical device development through the maze of product regulations.

 

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