Medical Device Single Audit Program (MDSAP) Training

This instructor-led one-day course covers the rationale for developing the Medical Device Single Audit Program (MDSAP), who the participating regulatory authorities are, and the specific audit criteria (including country-specific requirements) used during MDSAP audits.

This course discusses, in depth, the audit approach used by recognized MDSAP auditing organizations (AOs) as well as the MDSAP nonconformity grading system. Learners will also identify what MDSAP audit findings may trigger action from a participating regulatory authority.

By the end of this training, learners will be able to:

• Discuss the Medical Device Single Audit Program (MDSAP)
• Evaluate the MDSAP Quality Management System (QMS) audit nonconformity grading system and recognize grades that may trigger regulatory follow-up
• Identify the IMDRF MDSAP requirements and documents in use
• Explain the MDSAP Audit Approach

This instructor-led MDSAP training course is vital for any medical device quality professional — including quality directors, managers, engineers, and auditors — who is responsible for implementing a quality management system in accordance with ISO 13485:2016 and who plans to undergo an MDSAP audit.

Course tutors selected from the following:

Janet Book - Janet Book has worked in the field of quality for the past 35 years in a wide variety of industries, including blood banking, food processing, quality consulting, chemical, pharmaceuticals and medical devices, she has conducted internal and supplier audits utilizing many different industry-specific standards, due diligence evaluations as well as capability assessments. She has been involved with writing quality procedures; developing supplier, internal and corporate audit programs; developing quality management systems; and developing and presenting quality-related training and seminars. Janet is a certified Six Sigma Black Belt and served as an adjunct professor at Carnegie Mellon University. Recently, she earned her Certificate in Privacy Law and Cyber Security and worked in privacy providing guidance on quality, regulatory and compliance functions. She is a senior member of the American Society for Quality (ASQ), an ASQ Certified Quality Auditor (CQA), an ASQ Certified Quality Engineer (CQE), an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) and an RABQSA Quality Systems Lead Auditor.

Alexis Williams - Alexis Williams has worked in a variety of Quality and Regulatory Compliance functions for over 30 years with both world-wide and incubator organizations, supporting QMS development and remediation activities, transformational projects, audit/inspection execution and due diligence activities. She has diverse knowledge across global regulatory jurisdictions and a broad product portfolio specializing in Medical Device, IVD Device, Medical Device Software, combination products and IT solutions and services. Passionate about knowledge sharing, she is dedicated to equipping professionals with the skills needed to navigate complex regulatory landscapes. She is a Certified Medical Device Auditor, (CMDA) and active Member Leader of the American Society for Quality (ASQ) Great Britain Section Committee, currently fulfilling the roles of Voice of the Customer and Secretary.