NSF International is offering training for lead auditors of quality management systems (QMS) based on both ISO 13485:2016 and international Medical Device Single Audit Plan (MDSAP) requirements.
The five-day programme is the first international MDSAP and ISO-compliant medical device auditing course to be certified by the Chartered Quality Institute (CQI) / International Register of Certificated Auditors (IRCA).
Trainers include a former regulator, who helped develop the international MDSAP and medical device industry and has more than 20 years of industry and regulatory experience.
Executive vice-president of medical device training at NSF International Heather Howell said: "Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations.
"Students engaged in this course will gain knowledge and skills that took experienced auditors decades to gather."
Developed and led by instructors with years of experience at the British Standards Institute (BSI) and US Food and Drug Administration (FDA), NSF’s new course will teach students to plan, conduct, report, and follow up on QMS audits in accordance with MDSAP, ISO 19011, and ISO 13485:2016.
Howell added: "Given the medical device industry’s global supply chains and multinational organisations, a comprehensive training programme like this is incredibly valuable.
"The course provides extensive practical training and hand-on exercises, which will help prepare medical device auditors to identify critical nonconformities and meet international regulatory requirements."
The course is designed for medical device professionals with responsibility for conducting or implementing internal, supplier, corporate, or third-party audits. Quality directors, regulatory managers, and professionals responsible for managing internal, corporate, supply chain, or registration audit programmes may also benefit.
Regulatory affairs specialist for a UK-based medical device manufacturer Charmaine Scott-Hibbert said: "The course was hard work, really intense, but really rewarding.
"I really feel comfortable with ISO 13485 now. Getting to know the standard was very helpful for me. I feel confident that I can go and conduct any audit now."
NSF International’s CQI / IRCA-certified QMS Lead Auditor Training will be offered in the US and the UK in 2017. The next available courses will be held in:
- Manchester, England, UK – from 12 June to 16 June
- Irvine, California, USA – from 26 June to 30 June
- Reston, Virginia, USA – from 17 July to 21 July
NSF International also offers training as a private course available at client locations around the world.
Featured instructors scheduled for the 2017 courses include:
- Member of the Chartered Quality Institute (MCQI) and vice-president of education and medical devices at NSF International James Pink has more than 20 years of experience in the medical device industry, including auditing manufacturers worldwide for the BSI. He has provided training and education globally on medical device technologies, quality science, and auditing for more than 15 years.
- Executive vice-president of medical devices at NSF International Kim Trautman has more than 30 years of experience in medical device quality systems and international regulatory affairs. Her experience includes leading international initiatives for the FDA, specifically development of the international MDSAP.
- Executive director of MDSAP regulatory certification at NSF International Brian Ludovico has more than 20 years of experience in medical quality systems and certification requirements.
Before joining NSF International, he worked with the certification body TUV Rheinland of North America Group, where he was responsible for the Canadian medical devices conformity assessment system (CMDCAS) and the international MDSAP.