Quality Assurance & ISO 13485 Consulting
BioVision helps medical device manufacturers establish, implement, and maintain a Quality Management System (QMS) that meets ISO 13485 and regulatory expectations worldwide. We involve you at every step so the resulting system fits how your company actually works - rather than a binder that sits on a shelf.
Why your QMS is the foundation of everything
A compliant QMS underpins every market you enter. ISO 13485 is the internationally recognized standard for medical device quality management, and with the FDA's QMSR now harmonized with ISO 13485, a single well-built system can serve both U.S. and EU markets.
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QMS design and implementation from the ground up.
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ISO 13485 gap analysis and remediation.
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Risk management aligned with ISO 14971.
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Internal audits and audit readiness.
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QMSR alignment for U.S. market access.
How BioVision helps:
Frequently Asked Questions
What is ISO 13485?
ISO 13485 is the international standard specifying requirements for a quality management system for medical device organizations. Certification is widely expected by regulators and partners.
Does a strong QMS help with both FDA and EU markets?
Yes - especially now that the FDA's QMSR incorporates ISO 13485. A single harmonized QMS can support compliance in both jurisdictions.