ISO 13485 Implementation for Medical Device Quality Systems

Build a Compliant, Certifiable QMS Aligned with Global Regulations.

ISO 13485 Implementation That Supports Market Access and Compliance

Wintersmith Advisory helps medical device companies implement ISO 13485-compliant quality systems through structured planning, documentation, risk controls, and audit readiness—supporting regulatory and market access goals.

Why choose Wintersmith Advisory for ISO 13485 implementation?

• Full QMS design aligned with ISO 13485:2016 and regulatory expectations

• Risk-based planning and integration with ISO 14971

• Documentation support for procedures, records, and design controls

• Training and internal audit preparation

• Support through certification and regulatory inspection readiness

Medical Device Compliance Demands a Purpose-Built QMS

Medical device organizations face complex quality and regulatory requirements. Wintersmith Advisory offers end-to-end ISO 13485 implementation support to help manufacturers and service providers build quality systems that are both certifiable and practical.

From Gap Assessment to Audit Readiness

We begin with a gap analysis and risk assessment, then develop a QMS tailored to your operations, product risk class, and market requirements. Our services include documentation, design and development control integration, supplier management procedures, staff training, and audit preparation. Whether you're entering new markets, preparing for MDSAP, or aligning with EU MDR/IVDR, we’ll help ensure your system supports both compliance and performance.

Standards-Aligned. Globally Informed. Quality-Focused.

• ISO 13485:2016-aligned implementation

• Experience supporting FDA, MDSAP, and EU MDR readiness

• Risk-based, documentation-driven approach

• Support for certification audits and regulatory inspections

Let’s Build a QMS That Enables Innovation and Compliance

Bringing a medical device to market?
Let’s build a quality system that supports both compliance and innovation.