Contact: Deborah Madsen, Consultant
Speciality: Devices, IVD
Madsen QRC provides quality system and regulatory compliance consulting to the medical device and in vitro diagnostic device industries.
Areas of expertise include:
-Quality and Regulatory auditing, including FDA QSR, ISO 13485, IEC 62304, ISO 14971, MDSAP, MDD, IVDD, MDR, IVDR
-EU regulatory compliance, including development and review of technical files
-Comprehensive design and risk management reviews
-Development or remediation of design history files
-Assessment of compliance with harmonized standards
-Product safety submittals to NRTL’s (IEC 60601, IEC 61010)
-Quality Management system implementation and maintenance
-Implementation and validation of electronic quality management systems
-Quality system 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.
Years in business: Since 2014