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Medical Device Audits

Certain Medical Device manufacturers combine their product with drug items. This is a growing area in Life Sciences and could be tricky when it comes to validation. USDM not only has a long history of Medical Device experience, but we have also been involved in combination validation efforts, assessments, audits, remediation, qualifications, and vendor assessments. We can help firms by expediting the sometimes sketchy landscape of combo Drug/Device.

Specific device inspections go beyond the routine cGMP questions which are covered under predicate rule and consider guidances and ICH documents as well as ISO and FDA’s specific questions and concerns regarding these and newer devices such as PET drugs. Specific areas such as QA oversight program and QA/QC fall under QA and must have a program of audits and readiness in place.

One example is PAI readiness training which consists of CMC, DMF, executed batch (exhibit, pilot, biobatch) records with comparison to actual production activities with the firm’s management and staff. This enables your company to be able to answer investigator questions regarding your site with regards to NDA, devices and combinations.

Other areas include:

  • Facility- Specific Inspections: Stents, Inhalers, Patch, Iontopheretic, Positron Emission Tomography
  • Onsite mock audit
  • NDA, 510(k) and CMC Compliance
  • Device History Record and Device Master Records Regulatory Assessment
  • Drug/Device Sponsor/Owner Quality Assurance Oversight Programs