21 CFR 820 (FDA QMSR) and ISO 13485 Compliance

Quality Management System (QMS) Implementation and Support

NAMSA has a team of quality management consultants exclusively focused on helping medical device and IVD manufacturers comply with ISO 13485, US FDA Quality Management System Regulation (21 CFR Part 820), and other international quality regulations. While ISO 13485 is considered the bedrock standard for QMS compliance, the United States, Canada, Brazil, Japan, and other markets have specific additional requirements. Our team will help you navigate those requirements or build a QMS that accounts for them in the future.

QMS Compliance for Early-Stage Medical Device Companies

Companies in the development phase do not need a fully compliant QMS. However, that doesn’t mean compliance can be delayed until the product is ready to be commercialized. Certain components of your QMS should be implemented early to avoid regulatory issues later. Taking into account the cash flow and staffing realities of a smaller company, we focus only on procedures that are needed early on including:

• Design History File (DHF)
• Vendor/supplier management procedures
• Risk management procedures
• Document control procedures

We find that this approach works well, as it allows startup companies to build a framework for compliance with 21 CFR Part 820, without overburdening internal staff. As you get closer to production, we will work with you to add more required procedures until you are eventually fully compliant with the FDA QMSR and ISO 13485.

Support for Manufacturers with an Established QMS

For companies with an established QMS, our consultants are often asked to address specific issues aimed at improving process efficiency. We will first assess your current level of QMS compliance to uncover opportunities for improvement This involves conducting an in-depth assessment of your company’s processes, identifying strengths and weaknesses, and helping you develop and implement effective corrective action. This information is needed to make an informed assessment of the amount of time and resources required to comply with ISO 13485 and/or FDA QMSR. We often assist with:

• Improvements to Design Controls
• Device Master Record and Device History Record controls
• OEM supplier audits and purchasing controls
• Corrective and Preventive Actions (CAPA) improvement
• Standard Operating Procedure (SOP) writing and process mapping
• Process and software validation and verification
• Device labeling, packaging and UDI compliance
• Risk management procedure improvement
• Gap assessments and mock audits

We Deliver a Harmonized QMS That Meets International Requirements

When we implement a QMS for you, we ensure you are meeting FDA QMSR, EU MDR/IVDR, and other major market requirements, all in one seamless, cross-referenced QMS. As you grow and consider exporting to countries such as Brazil and Japan, we can help you add procedures necessary to meet the specific additional requirements of those markets.