Quality Management Systems (QMS)
Support organizations in establishing, optimizing and maintaining compliant and efficient QMS.
How we help
- QMS design aligned with ISO 13485, 21 CFR Part 820/QMSR, MDSAP, and MDR (EU 2017/745)
- Scalable QMS architectures for organizations of any size or maturity
- Gap analyses and implementation roadmaps
- Cross‑functional CAPA planning and QMS improvement initiatives
- Process landscape mapping tailored to organizational and product complexity
- Refinement of Quality Manuals, SOPs and templates
- Strengthening Post‑Market Surveillance, including complaint handling, adverse event reporting, and FSCAs
Interim QA Support, Full- or Part-Time
Immediate QA leadership and operational support when compliance issues or staffing gaps cannot wait.
What we provide
- Acting as Quality Manager, Management Representative, and/or PRRC
- Leading QMS implementation projects or updates to new activities
- Managing device or device‑constituent development projects
- Closing CAPAs, deviations, complaints, audit findings, and change controls
- Independent, unbiased QA support
- Supplier qualification and supply chain remediation
- Risk Management activities in accordance with ISO 14971
Audit
IRCA‑certified Lead Auditor (Notified Body trained) with experience conducting more than 80 internal, supplier and Notified Body audits
Audit services
- Audits against ISO 13485, 21 CFR Part 820/QMSR, MDSAP, and MDR
- Audit preparation, execution, and follow‑up
- Mock audits, internal audits, and supplier audits
- Risk‑based internal and supplier audit planning
- Auditee training and coaching
- Due diligence audit preparation and execution
Drug-Device Combination Products
Supporting manufacturers in navigating EU and US regulatory expectations for Drug–Device Combination Products (DDCP).
Specialized support
- Updating QMS to comply with EU MDR and/or US 21 CFR Part 4 (streamlined or full Part 820 approach)
- Integrating regulatory requirements into a practical, fit‑for‑purpose QMS
- Ensuring readiness for timely submissions and post‑market operations
- Supporting Economic Operators in meeting MDR obligations (Articles 11–14)
Training
Tailored training programs designed to strengthen competence, confidence, and compliance across your organization.
Training topics
- QMS requirements: ISO 13485, 21 CFR Part 820/QMSR, MDSAP and EU MDR
- Fundamentals of Drug–Device Combination Products (EU MDR and US 21 CFR Parts 3 and 4)
- Audit and auditor training: preparation, execution, and closure
- ALCOA+ principles and Good Documentation Practice
Facilitation & Coaching
Helping teams collaborate effectively, plan strategically, and embed a sustainable quality mindset.
Facilitation and coaching services
- Workshops to map the full QMS landscape or integrate new requirements
- Planning sessions for Design Transfer, Design Control and related activities
- Facilitation focused on building and sustaining a strong quality culture
- Auditee training and coaching