Course description

This 1 day training course gives participants an in-depth knowledge of EN ISO 14971 requirements and its application.

 

It guides organisations through the regulatory requirements all type of devices, active or non-active sterile devices.

 

It is making the link with MDR and MDD requirements and explains how businesses can guarantee safety claims of medical devices.

 

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Learning objectives / course outcomes

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

Identify the links between MDD/ MDR and EN ISO 14971

• Explain how the requirements relate to the product lifecycle

• Define the risk management requirements

• Define the key documents of the risk management file

• Define the key deliverables for risk management documentation

 

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Who is the course suitable for?

• Regulatory quality managers and personnel

• Design and development managers and personnel

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Course outline

  I-  Introduction

a. Objectives of the course

b. Structure

c.  Introduction and international context of application

d.  Quick test

II-  Risk management plan

a. Requirements

b. How to write a risk management plan

c.  Application to sterile medical device

d. Application to active medical device

e. Quick test

III- Risk analysis- FMEA

a. Requirements

b. How to identify the hazards

c. What type of FMEA to do

d. Application to sterile medical device

e. Application to active medical device

f. Quick test

IV- Risk management report

a. Requirements

b. How to write a risk management report

c. Application to sterile medical device

d. Quick test

V- Conclusion

a. Content of a risk management file

b. Skills learned

c. Test

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Prerequisites

 Participants should have a basic knowledge of:

-        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. 

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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.