Medical Device Single Audit Program (MDSAP) Auditor Training
The aim of this course is to provide learners with an appreciation or the knowledge and skills required to complete an audit against the IMDRF Medical Device Single Audit Program (MDSAP AU P0002.004) for medical device quality management based on ISO 13485:2016 and international regulatory bodies medical device regulations. Audit principles in accordance with ISO 17021.
More information coming soon!
Course Duration:16 Hours
FormatBlended Course (6hrs Online & Self-Paced + 1-day Virtual Classroom)
Delivery Options & Discounts
- Available as a blended course including virtual classroom
- Available on select public dates & for in-house training for groups of 5+!
- Multi-Person Discount: Book 3, get a 4th Place Free (Same Course & Dates Apply)
PriceNot Yet Available
- Comprehensive Course Manual
- Virtual Instructor Assistance – Phone & Email Support (Online Modules)
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|Start Date||Location||Cost||Duration||Onsite/Virtual Classroom|
| - ||6 Hours (Online & Self-Paced) + 1 Days (Virtual Classroom)|
- Knowledge of the requirements of ISO 13485, which may be gained by completing a CQI and IRCA Certified ISO 13485:2016 Foundation training course or equivalent.
- The relationship between ISO 13485 and applicable international regulatory requirements for medical devices
- Commonly used quality management terms and definitions within ISO 13485 and ISO 9000
- The process approach used in quality management
- Understand risk management principles related to the design of a medical device quality management systems (e.g. through ISO 14971).
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