Madsen QRC, LLC, Quality and Regulatory Consulting

Madsen QRC provides quality system and regulatory compliance consulting to the medical device and in vitro diagnostic device industries.

Areas of expertise include:

  • Own and operate consulting enterprise providing advice, assistance and guidance to the medical and in vitro diagnostic device industry in the areas of quality systems, ISO 13485, IEC 62304, and MDSAP implementation and compliance, and regulatory submissions, including MDR, HC, FDA 510(k), ROHS.
  • Handle a wide array of auditing and compliance work to help clients ensure applicable product standards and regulatory requirements are met.
  • Train, mentor, and supervise quality engineers at customer sites to ensure timely completion of quality and regulatory projects.
  • Assemble and review technical and risk management files.
  • Perform comprehensive design and risk management reviews.
  • Provide product testing protocol development and assistance with obtaining safety certifications (IEC 60601-1, IEC 61010-1 series of standards; UL, TUV, Nemko, Intertek).
  • Implement, validate and populate electronic document control process.
  • Implement and maintain quality management systems.
  • Remediate quality systems.
  • Conduct internal and supplier audits in accordance with ISO 13485:2016, IEC 62304:2015, CMDR, FDA 21 CFR Part 820, MDD, MDR, IVDD, IVDR, MDSAP, JPAL, TGA, ANVISA, Korea MDA, UK Regulation for Medical Devices.
  • Lead management review meetings.
  • Prepare and present quality system, auditor and regulatory compliance training.

Deborah Madsen has over 30 years of experience in the design, manufacture, quality assurance and regulatory compliance of medical and in vitro diagnostic medical devices. Over a period of 21 years, Deborah held several roles at UL, including product safety engineer, lead auditor, instructor, and technical file assessor. Over a period of 8 years at Beckman Coulter, Deborah managed the in house product safety, EMC, reliability and product performance laboratory. More recently, Deborah has held roles as Director of Quality and Regulatory for medical device and IVD start-ups.  Deborah holds a degree in Electrical Engineering, and is a Registered Professional Engineer in the state of California.