Design Controls for Medical Devices and IVDs
NSF International’s web-based virtual training course provides a basic understanding of Design Controls for medical devices and IVDs. Providing knowledge to comply with US FDA’s Quality System Regulation, the quality management system international standard ISO 13485:2016, and the European Union Medical Device Regulation (EU MDR). Learn from global Quality Systems expert, Kim Trautman, a former U.S. FDA official. Kim also authored the current U.S. FDA Quality System regulation and is a recognized leader of continued global regulatory harmonization efforts.
What You Get
- A 2 hour video presentation from quality system expert, Kim Trautman
- Competency assessment certification to add to your company’s training files (2.5 hours, including exam)
Upcoming start dates
- Self-Paced Online
Training Course Content
By the end of this course, you should be able to:
- Identify design control requirements based on US FDA quality system regulation, ISO 13485:2016, and EU MDR.
- Recognize how risk management ties in to the design control process.
- Recognize FDA’s auditing process and expectations of design controls.
- Identify appropriate application of design control requirements.
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Average rating 5
The instructors kept it interesting with real life lessons by providing perspective. They both approached the material by pointing out why we need to do what we do versus reciti...
Engaging trainers and good use of tools; Zoom meeting features were leveraged quite well with breakout sessions.
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.