Developing Quality Systems and supporting continuous improvement initiatives to achieve compliance with global regulatory requirements including the FDA’s Quality System Regulation, Medical Device Single Audit Program (MDSAP), ISO 13485, ISO 9001, ISO 14971, ISO 62304 and IEC 60601-1
Establishing FDA inspection readiness
Preparing for ISO 13485 and ISO 9001 certification audits
Performing simulated FDA inspections and ISO certification audits
Completing QMS and HIPAA internal audits to fulfill your internal audit schedule and/or to offer a peripheral perspective
Completing gap analysis between your Quality System and intended market regulations