Design Controls for Medical Devices Training Course
October 27 – 28, 2021
This course provides an understanding of Design Control principles and the design and development regulatory requirements relative to US 21 CFR Part 820, ISO 13485:2016 and EU MDR; as well as practical examples to minimize inefficient executions and documentation practices. Students not only learn important requirements related to design controls, but they also benefit from open dialogue and sharing of current design and development processes highlighting how misperceptions of regulatory requirements have led to less than optimal practices. This course provides knowledge to assist in all phases of medical device design and development projects, as well as retrospective Gap Analysis of Design History Files, which will help prepare for the development of new Technical Files under the EU MDR and IVDR.
This live virtual instructor led 2-day course is highly interactive and provides students with an understanding of the risk management definitions and principles of ISO 14971, and specifically addresses the regulatory expectations relative to Medical Device Design Control requirements.
Upon completion of this course, students will be able to:
· Properly identify design control requirements of the US Quality
System Regulation, EU MDR/IVDR and ISO 13485
· Describe the design review, design verification, and design validation processes
· Understand the importance if the Design History File (DHF)
· Understand the links between design controls and risk
· Explain the design transfer process
· Understand post-market surveillance requirements in relation to
· Recognize potential exemptions from design control
· Conceptualize graphically a design control process
Who Should Attend
This class is vital for any medical device research and development professional, regulatory scientist, and/or clinician involved in developing and manufacturing medical devices. This course provides critical knowledge for both Regulatory Affairs and Quality Assurance professionals.