Quality Management

An effective Quality Management System (QMS) ensures a quality-oriented, compliant and efficient organization culture. The QMS is the foundation for any device manufacturer's success. We have deep experience assessing, revising, and implementing ISO 13485 compliant QMS's for a wide range of medical product categories.

Whether you need a comprehensive QMS tailored to your medical product needs, or you need to refresh your existing QMS to meet updated or new regulations, we have deep expertise to assist you along the way. We have numerous partners that offer world-class eQMS's that meet FDA and international standards, and we have helped many customers update and customize their policies and processes to gain compliance, efficiency and a competitive advantage.

FDA and International Standards and Regulations

Quality Expertise

With more than 150 combined years of experience, Medical Systems Consult has deep expertise with a wide range of international quality standards and regulations, including:

  • ISO 13485 - Medical devices — Quality management systems — Requirements for regulatory purposes
  • ISO/IEC 60601-1/80601-1 family of standards, including -1-x collateral's and -2-x particular's
  • ISO 14971 - Medical devices — Application of risk management to medical devices
  • IEC 62366 - Medical devices — Part 1: Application of usability engineering to medical devices
  • ISO/IEC 62304 - Medical device software — Software life cycle processes
  • ISO/IEC 82304 - Health software — Part 1: General requirements for product safety
  • ISO/IEC 81001-1 - Health software and health IT systems safety, effectiveness and security
  • ISO/IEC 81001-5-1 - Health software and health IT systems safety, effectiveness and security
  • ANSI/AAMI SW96 - medical device security—Security risk management for device manufacturers/
  • FDA 21 CFR Part 820 - Quality System Regulation
  • EU MDR 2017/745 - European Union Medical Device Regulation

Quality is everyone's responsibility.

Our quality services

  • Quality system audits and gap assessments
  • Mock FDA audits, MDSAP, CE Mark, and ISO audits
  • Quality training
  • Third-party supplier audits
  • Design quality and quality assurance professionals
  • Response to authorities for FDA 483 warning letters
  • Supporting consent decrees, and ISO audit observations
  • CAPA remediation planning and support
  • Post-market surveillance (PMS) support
  • ALM and PLM tool integrations to streamline quality compliance

Partner Experts

Our international quality consultants have decades of hands-on quality certification and implementation experience, and have successfully gained many ISO certifications for a wide range of Class II and Class III medical devices. All successful medical device programs are based on a robust quality management system, which lays out a clear path to premarket and postmarket compliance. We have helped both start-ups and mature companies identify applicable state-of-the-art standards required and a quality management system that supports day-to-day work and encourages a high quality culture.

Need FDA or EU MDR/IVDR audit assistance?

Our quality consultants have deep, firsthand experience with FDA and EU MDR/IVDR audits and can help you minimize business risk.

Are you a start-up?

We have helped numerous start-ups develop solid quality management systems to clear FDA and EU MDR regulatory requirements and establish a baseline to continue to build on for future product approvals.

Are there gaps in your QMS holding up projects?

We are ready to help you bring up to date your existing QMS to meet the latest regulatory requirements and enable your product development projects to accelerate to market, e.g., post-market surveillance, cybersecuirty framework, AI risk management framework.