An NSF International Company Introduction to Medical Device Quality Management Systems ISO 13485 CFR 21 Part 820
PrintPart of the Medical Devices Regulatory Strategy Module 5 - attend one or all of the sessions
Dates:
Monday 07 April 2025
Venue:
AMP Technology Centre, Sheffield, UK
Cost:
£600.00 excl VAT - £720.00 inc VAT
Type: Medical Devices
About this course
In order to place a medical device onto the market or become a key supplier within the medical devices industry, you need to have a robust understanding of the Quality Management System Standard ISO 13485 as well as common worldwide requirements such as those of the US (CFR 21 Part 820), Japan (Ordinance 169) and Canada, to name a few.
This course will enable you to navigate the requirements and get you on course towards your implementation project or to speak with authority on the regulatory expectations and customer expectations of working within a medical device regulated environment.
Who should attend
- Professionals who currently work within other sectors such as pharmaceutical, cosmetic and allied industries who need to become aware of the medical device requirements. Regulatory and GMP requirements will be of particular benefit as the course is aimed towards those working in these types of industries and provides a foundation knowledge of medical device regulations, enabling you to move into our range of implementation courses
- Management personnel responsible for familiarising themselves with the requirement of the medical device industry
- Senior management wishing to understand the basics associated with medical device quality management systems
- Quality assurance, regulatory, development and manufacturing personnel moving into projects with medical device regulatory interactions
