Medical Device QMSR and ISO 13485
Help your device quality team connect ISO 13485 with FDA's current QMSR framework, identify relevant evidence and prepare for practical quality-system responsibilities.
Private group · Scope-based quotation · Live online · On-site by arrangement
Indicative syllabus
- QMSR under 21 CFR Part 820 and the ISO 13485 relationship
- Management responsibility, risk-based processes and documentation
- Design, production and supplier controls relevant to the agreed activities
- Complaints, traceability, CAPA and other FDA-specific interfaces
- Internal audits, management review and inspection evidence
- Practical case exercises and an agreed assessment
What the certificate means
An FDABridge certificate records completion of the agreed course and its participation or assessment requirements. It is not FDA approval, personnel certification or certification of your organization.
Training is separate from regulatory filings, consulting, remediation and certification. The final scope and price are stated in the written proposal.
Learning outcomes
- Understand the relationship between QMSR and ISO 13485:2016.
- Map key quality-system activities to their supporting records.
- Identify device-specific topics requiring deeper technical assessment.
Who it is for
Medical-device manufacturers, quality and regulatory teams, internal auditors and consultants.
What we need to tailor it
- Device types, establishment activities and target markets
- Existing quality-system and ISO 13485 status
- Participant roles, experience and group size
- Learning priorities, preferred language and delivery period
Scope boundaries
- This is not ISO 13485 certification of your organization or an FDA clearance course.
- An ISO 13485 certificate does not by itself demonstrate every QMSR obligation has been met.
- 510(k), De Novo/PMA submissions, clinical evidence and technical testing are separately scoped.
What your written proposal confirms
Training is separate from regulatory filings, consulting, remediation and certification. The final scope and price are stated in the written proposal.
An FDABridge certificate records completion of the agreed course and its participation or assessment requirements. It is not FDA approval, personnel certification or certification of your organization.