Medical Device Quality Management Systems (QMS)
A strong medical device QMS is more than a regulatory requirement—it's a foundation for risk control, patient safety, and global market access. Wintersmith Advisory provides specialized consulting services to help organizations design, implement, and maintain quality management systems tailored to the medical device industry.
Our services align with international standards and regulatory frameworks, including:
ISO 13485:2016
FDA 21 CFR Part 820 (QSR)
EU MDR and IVDR
MDSAP (Medical Device Single Audit Program)
Our Medical Device QMS Services
1. QMS Development & Implementation
Customized QMS aligned with ISO 13485 and FDA requirements
Modular SOPs, forms, and process controls
Design and production lifecycle integration
2. QMS Gap Assessments
Evaluate your current state against key standards
Prioritize remediation and streamline your certification timeline
Risk-based and stage-appropriate reviews
3. Audit & Inspection Preparation
Mock audits using ISO 19011 principles
FDA QSR and MDSAP inspection readiness
Internal audit training or full-service execution
4. Post-Market Surveillance & Risk Management
Complaint handling, vigilance, and reporting systems
Integration with ISO 14971 risk management processes
CAPA, change control, and field safety procedures
5. Digital QMS Transition Support
Transition from paper-based to electronic QMS (eQMS)
Vendor selection and implementation guidance
Ensure validation, data integrity, and traceability
Who We Help
Early-stage medtech and digital health startups
Contract manufacturers and OEMs
International device companies entering U.S. or EU markets
Organizations undergoing FDA, ISO, or MDSAP audits
Why Work with Wintersmith Advisory?
Cross-Standard Expertise: We bridge ISO 13485, FDA QSR, and MDR requirements
Startup-Friendly: Scalable, right-sized systems for fast-moving teams
Hands-On Support: From design to deployment, we don’t leave you guessing
Audit Success: Proven record guiding clients through successful certifications
Related Services
ISO 13485 Consulting
EU MDR Implementation Support
FDA QSR Remediation Projects
Medical Device Risk Management (ISO 14971)
eQMS Implementation Planning
Ready to Strengthen Your QMS?
Let’s build a medical device quality system that supports compliance, quality, and growth.
Schedule a free call to learn how we can help.
Contact us.
info@wintersmithadvisory.com
(801) 558-3928