Developing a new medical device for commercialization is a complex process. The FDA has guidelines that provide a framework for designing and manufacturing medical devices.
This course will provide a detailed and practical overview of the design control process for medical device design and development. The course will cover design control under the FDA Quality System Regulation (21CFR820.30) and international Standard ISO 13485 for Quality Management Systems, in addition to the practical application in the design and development of electronic hardware, software, mechanical elements and labels. The course will also cover related aspects of associated Standards and Regulations such as Risk Management (ISO 14971), Usability (IEC 62366-1) and Software lifecycle (IEC 62304).
- Initial Design Control Process
- Design Output Process
- Verification and Validation
- Design Transfer
- Tagging, Tracing, Packaging and labeling
- Risk Analysis
Practical Skill Development:
- Understand the overall Design Control process
- Understand the (10) elements of Design Control
- Know how to apply each element of Design Control to the most common design disciplines
- Know how to do Design Risk Analysis
- Know how to do tracing between Risk Analysis, Design Input, Design Output, Design Verification and Design Validation
- Know practical methods for Design Transfer and Design Review
Course Number: BIOL-40324
Credit: 3.00 unit(s)
Related Certificate Programs: Regulatory Affairs for Medical Devices
+ Expand All
6/26/2023 - 8/28/2023
This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Bob Duffy has over 25 years in medical device design and development, on top of over 15 years in manufacturing. His product design experience includes pulse oximeters, anesthetic gas monitors, infusion pumps, interventional cardiovascular devices, multi-parameter monitors, nerve and muscle stimulators, and other devices. His manufacturing experience includes electronic assembly, mechanical part manufacturing and materials management in California’s Silicon Valley. He was an inventor on (13) medical device patents. He was the original project leader for one of the most successful medical devices in the past decade, providing in excess of $1 billion in revenues. Duffy heads up his own consulting company, Bob Duffy Associates, helping medical device companies overcome hurdles i...Read More
No refunds after: 7/3/2023.
6/26/2023 - 8/28/2023
You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
There are no sections of this course currently scheduled. Please contact the Science & Technology department at 858-534-3229 or email@example.com for information about when this course will be offered again.