Ensuring Safety and Compliance in the Medical Device Industry
BQCIS Medical Device Audits help manufacturers demonstrate compliance with stringent global regulations. These audits confirm that Quality Management Systems are robust, documented, and effective—ensuring that medical devices are consistently safe, compliant, and traceable.
Our auditors assess conformance to ISO 13485 and complementary frameworks such as ISO 14971 (Risk Management), FDA QSR / 21 CFR Part 820, and the EU Medical Device Regulation (MDR). We perform gap analyses, pre-assessments, and second-party supplier audits that strengthen readiness for certification or regulatory inspection.
With deep industry experience in design controls, validation (IQ/OQ/PQ), sterilization, and UDI traceability, our experts provide actionable findings to drive continual improvement, maintain regulatory compliance, and uphold patient safety.
Key Medical Device Audit Activities
Key Benefits of Medical Device Audits
Ensure Patient Safety
Confirms that risk-management and quality-assurance processes effectively prevent device failures and protect end-users.
Achieve Regulatory Compliance
Demonstrates adherence to ISO 13485, FDA QSR, and EU MDR requirements—supporting successful inspections and certifications.
Facilitate Market Access
Certification readiness underpins global distribution approvals and accelerates entry into regulated healthcare markets.
Manage Supplier Risk
Ensures critical suppliers maintain compliant QMS processes, safeguarding the integrity and reliability of your device supply chain.
Success Story
ISO 13485 Gap Analysis Prepares Startup for FDA Inspection
A medical-device startup preparing for its first FDA inspection required assurance that its newly developed QMS met ISO 13485 and QSR expectations.
BQCIS conducted an ISO 13485 and FDA QSR pre-assessment audit emphasizing Design Controls, Risk Management (ISO 14971), and Document Control. The detailed review identified compliance and traceability gaps.
Corrective actions were implemented before formal audits, resulting in a successful ISO 13485 certification and an FDA inspection free of major observations—positioning the company for rapid market approval.