Audits & Assessments

As a medical device or IVD manufacturer, the execution of your audit program can be challenging, requiring sufficiently trained and qualified auditors to meet the requirements in the complex regulatory landscape in which you operate.

Qserve supports your internal and supplier audit program by conducting audits for your organization.

Benefits of using Qserve include:

• - Highly-skilled, trained, and certified (Lead) Auditors.
• - Fully objective and impartial to the subjects audited.
• - Experienced in nearly any medical device product area (non-active and active medical devices, including SaMD, IVD, combination products).
• - Deep expertise in a broad range of regulatory quality management system requirements, standards and country-specific requirements.