Design Controls for Medical Devices and IVDs Training Course
April 5 – 6, 2022
This course is 2 days. This course will provide you with an understanding of the actual risk management and design and development regulatory requirements relative to FDA’s 21 CFR 820, ISO 13485:2016 and the new EU regulations; as well as practical examples as to how to minimize inefficient executions and documentation practices. The greatest benefits of this course is gained through open dialogue and sharing of current design and development processes to highlight how misperceptions of regulatory requirements have led to less than optimal practices. This course will provide you with knowledge to assist in all phases of your design and development projects, as well as retrospective Gap Analysis of Design History Files in preparation for the development of new Technical Files under the EU MDR and IVDR.
Who Should Attend
This class is vital for any medical device R&D engineer, scientist, and clinician as well as Regulatory Affairs and Quality Assurance professionals.