Madsen QRC, LLC, Quality and Regulatory Consulting

Email: Deborah@madsenqrc.com

Phone/text: 909-720-9071

Madsen QRC provides quality system and regulatory compliance consulting to the medical device device industry.

Areas of expertise include:

• Providing advice, assistance and guidance to the medical device industry in the areas of quality systems, ISO 13485, FDA QMSR, IEC 62304, and MDSAP implementation and compliance.
• Internal and supplier audits in accordance with ISO 13485, FDA QMSR, MDR, MDSAP, Korea MDA, UK Regulation for Medical Devices.
• Assistance designing to meet applicable product safety standards and regulatory requirements.
• Auditor and quality system training.
• Perform comprehensive design and risk management reviews.
• Provide EMC and product testing protocol development and assistance with obtaining safety certifications (IEC 60601-1, IEC 61010-1 series of standards; UL, TUV, Nemko, Intertek).
• Implement and maintain quality management systems.
• Lead management review meetings.

Deborah Madsen has over 35 years of experience in the design, manufacture, quality assurance and regulatory compliance of medical devices.  Deborah has held roles as NB auditor, product safety engineer, 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.