Audits & Assessments
With our practical approach, we support the internal audit and supplier audit programs to assess the effectiveness of the company’s quality management system.
Certified (lead) auditors
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.
Satisfied Clients
Our Audits & Assessments covers multiple disciplines. Discover all of them:
Audits & Inspections
We conduct audits & inspections for your organization:
Internal audits
Supplier audits
Clinical audits
EU MDR/IVDR Mock audits
MDSAP Mock audits
FDA Mock Inspections
NMPA Mock Inspections
Assessments
QMS GAP assessment
Technical documentation
GAP assessments
Notified Body TD like review.
Mergers & Acquisitions
Regulatory due diligence addresses potential regulatory risks related to products and markets.
