Maintain Your ISO 13485 QMS with Confidence

Sustain Compliance. Manage Risk. Stay Audit-Ready.

Ongoing ISO 13485 Maintenance That Supports Certification and Performance

Wintersmith Advisory provides structured ISO 13485 maintenance services to help medical device companies keep their Quality Management Systems effective, compliant, and aligned with regulatory expectations.

Why trust Wintersmith Advisory with your ISO 13485 maintenance?

• Internal audits and nonconformance tracking

• Document and procedure updates

• Design and development file reviews

• CAPA and risk management system support

• Supplier control and recordkeeping oversight

• Readiness for certification and regulatory audits (FDA, MDSAP, MDR)

ISO 13485 Maintenance Is About More Than Staying Certified

ISO 13485-certified systems require ongoing attention—not just to maintain compliance, but to ensure product safety, traceability, and regulatory readiness. Wintersmith Advisory provides medical device organizations with structured QMS maintenance services that support continuous improvement and protect certification status.

Comprehensive QMS Support for Evolving Needs

Our services include internal audits, documentation control, risk file reviews, supplier management, CAPA oversight, and employee training refreshers. We help you keep your system aligned with evolving regulations, customer requirements, and production changes—whether you’re preparing for a surveillance audit or managing your QMS through active product development.

Compliance Backed by Standards and Real-World Experience

• Maintenance aligned with ISO 13485:2016 and ISO 14971

• Support for FDA, MDSAP, and EU MDR environments

• Medical device documentation and traceability expertise

• Integrated CAPA, risk, and audit support

Let’s Keep Your QMS Compliant and Inspection-Ready

Need help maintaining your ISO 13485 certification?
Let’s build a maintenance plan that keeps your QMS compliant and inspection-ready.