Gap, Supplier Qualification, Internal, and Precertification Audits
How Can We Assist You?
Auditing Services
We are certified auditors and have extensive industry experience regarding:
-
Medical Device Single Audit Program (MDSAP)
-
21 CFR Part 820 / 4
-
ISO 13485 and ISO 9001
-
European Device Medical Regulation (MDR)
-
European IVDR
-
Standards / Auditor Training
Our team will provide an unbiased, thorough evaluation and have extensive experience with the following types of audits:
-
Medical Device Single Audit Program
-
Certification Audits
-
Internal Audits
-
Supplier Audits
-
Mock FDA Inspections
-
Product/Process Audits
-
Desktop Audits
-
Due Diligence
-
Quality System Inspection Technique (QSIT)