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:
Auditing
Qserve supports your audit program by conducting audits for your organization.
Internal audits
Supplier audits
Clinical audits
IVD laboratory audits
Device registration audit
Mock inspections
Preparation for regulatory authority or notified body audits through Mock Audits and Inspections:
EU MDR/IVDR Mock Audit
FDA Mock Inspection
NMPA Mock Inspection
MDSAP Mock Audit.
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.
