Achieving and Maintaining Global Medical Device Regulatory Approval
Compliance with evolving device regulations—such as the FDA QSR and EU MDR 2017/745—demands a certified ISO 13485 QMS and rigorous oversight from design through post-market surveillance.
BQCIS provides auditing, testing, and advisory support to ensure your medical devices meet global regulatory, technical, and clinical requirements. We help you establish robust systems for design control, documentation, and CAPA management that stand up to regulatory scrutiny.
Our services cover all device classes and include full technical-file preparation and QMS alignment for FDA 510(k) and CE Mark submissions—reducing risk and accelerating global market entry.
Key Medical Device Regulatory Services
Key Benefits of Medical Device Compliance
Global Market Access
Achieve CE Mark and FDA 510(k) approvals with full regulatory documentation and certification readiness.
Streamlined Certification
Accelerate approvals through structured QMS implementation and proactive regulatory alignment.
Regulatory Confidence
Demonstrate full conformity with MDR and ISO standards through traceable, auditable documentation.
Sustained Compliance
Ensure lifecycle compliance via continuous surveillance, vigilance reporting, and internal audits.
Success Story
MDR Transition Strategy Secures EU Market Access
A Class II device manufacturer faced tight MDR transition deadlines and lacked resources to update technical and clinical documentation.
BQCIS performed a QMS gap analysis, rebuilt CERs and Risk Management Files, and implemented MDR-compliant post-market processes.
Updated files were accepted by the Notified Body on first review, preventing CE Mark lapse and maintaining uninterrupted EU market access.