What is the webinar about?
Join us for our engaging and informative webinar, “ISO 13485 and MDSAP – A Beginners Guide,” designed to provide a comprehensive introduction to these essential assessments.
In this beginner-friendly session, we’ll discuss what the ISO 13485 standard and Medical Device Single Audit Program (MDSAP) cover. Our expert speakers will guide you through the fundamental principles, requirements, and benefits of ISO 13485 and MDSAP certification for organizations.
Who should attend?
- Newcomers to medical device quality management
- Quality professionals looking to broaden their understanding of ISO 13485 and MDSAP
- Those interested in understanding the similarities and differences of ISO 13485 and MDSAP
What will participants gain?
- Awareness of ISO 13485 and MDSAP fundamentals: Get to know which markets MDSAP covers and the audit cycle.
- Core requirements: Learn about the key elements of ISO 13485 and MDSAP audit processes, including documentation, and country specific regulatory requirements.
- Implementation steps: Discover practical tips and timelines for starting your journey towards ISO 13485 and/or MDSAP certification.
Speakers
Bill
Enos
Global Assessment Delivery Director, Regulatory Services, BSI
Bill Enos currently holds the position of Global Assessment Delivery Director for the Regulatory Services division. He began his BSI career in 2004 as the first full time microbiologist in the Americas after almost 11 years in the medical device and pharmaceutical testing laboratory industry. In 2017, Bill assumed the role of Senior Commercial Operations Director for the Americas region, both prior to, and following, the creation of the current RS division. Bill formally began his current role in January of 2022. Bill’s academic background includes a Bachelor of Science degree in the disciplines of Biology and Chemistry from Western New England University, as well as continuing education in Financial Accounting from Harvard Business School.
Linda
Moon
Head of Global Quality & Accreditation, Regulatory Services, BSI
Linda joined BSI in 2001 as a medical device QMS auditor following a background in IVD technologies in research and development in an academic setting and at the NIBSC. In 2010 she joined the IVD team as a technical specialist and scheme manager before moving into GQA in 2015. She became the manager of the team in 2021.
Email: medicaldevicesmarketing@bsigroup.com
Phone: +44 3450809000
To find out more about MDSAP, follow the link here.
To find out more about ISO 13485, follow the link here.
