Course Description

This course is designed to provide participants with understanding of the EN ISO 11137-1 & -2 requirements for sterile medical devices and compliance with EU MDR and UK MDR.

This 1 day training provides an in depth knowledge of the EN ISO 1137-1 to -3 requirements and study cases.

 

 

 

Learning objectives / course outcomes

On completion of this training, participants will be able to :

• Identify the links between UK MDR/ EU MDR and EN ISO 11137-1, -2, -3

• Define the requirements for the validation of sterilization

• Define the type of dosimeters used and its compliance with ISO ASTM 52628

• Define the requirements for the sterilization in routine and the release of batches

• Identify the content of a validation report of sterilization

 

Intended audience

• Regulatory, quality assurance managers and personnel

• Design and development managers and personnel

• Quality control personnel

 

Content of the course

I- Introduction

II- Microbiology: Bioburden et sterility testing

III- Design of the device’s material and interaction with the irradiation

IV- What type of dosimeter to use

V- Validation- IQ, OQ, PQ

VI- Requalification

VII- Controls in routine, release of sterile products

VIII- Impact of the medical device’s modification on sterilization process and extension of range

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Prerequisites

Participants should have basic knowledge of microbiology and packaging requirements.

 

How will I learn?

We use interactive learning techniques, keeping the course varied and with applications and study case. Our tutors are the best and will make sure your learning needs are met. Choose between online or in-company courses tailored to your business.

 

Price

 We are providing online training course for £450 per person. We also offer this training at a special price for student, for more details contact us at office.mdsspro@gmail.com. 

 

On site training is tailored by on your needs. For more details contact office.mdsspro@gmail.com.