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)

Flat-style illustration of a medical device QMS concept, featuring a monitor, ISO 13485 checklist, infusion pump, shield with a checkmark, and flowchart symbols.

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