Course description

This 1 day training course gives participants an in-depth knowledge of IEC 62366 requirements and its application.

 

It guides organisations through the regulatory requirements for:

• active medical devices

• non active medical devices

 

It focuses on MDR and MDD compliance and explains how businesses can guarantee safety claims of medical devices.

 

Learning objectives / course outcomes

By the end of the course, participants will be able to:

• Identify the links between MDD/ MDR and IEC 62366

• Explain terms and definitions

• Define the usability requirements

• Identify the methodology used

• Develop a usability engineering process

• Define the key documents of the usability file

 

Who is the course suitable for?

• Regulatory and quality assurance managers and personnel

• Design and development managers and personnel

• Risk management personnel

• Project managers

 

Course outline

I- Introduction

II- Requirements from the standard

III- Differences between IEC 62366:2008 and IEC 62366:2015

IV- Implementation of the requirements

V- Conclusion

VI- Assessment/test

 

Prerequisites

Participants should have a basic knowledge of:

•  ISO 14971 and quality management systems and/or

•  the medical device industry

 

What format does the training take?

MDSSPRO uses interactive teaching techniques, keeping the course varied and stimulating through exercises, working applications and case studies.  Experienced and knowledgeable industry-leading tutors ensure individuals stay engaged throughout the course and that the learning objectives are met.

 

The course can be run online or onsite at company offices.

 

MDSSPRO’s online training course is powered through a Performant Software platform. Online tutors are available throughout the length of the course offering full support to course participants, answering questions, offering advice and explaining course material as required. 

 

Price

Online training course - £400 per person. We also offer this training at a special price for student, for more details contact us at admin@mdsspro.com. 

 

On-site training courses are customised to meet specific business requirements.  Contact admin@mdsspro.com for costs and further information.