ISO 13485:2016 & The Medical Devices Directives

Home / Life Sciences / ISO 13485:2016 & The Medical Devices Directives
ISO EN 13485:2016 is the global Quality Management Systems Standard used by medical device manufacturers to meet certain requirements to support the safety and effectiveness of the products they sell. Notified Bodies can use this standard when assess... Read More

ISO EN 13485:2016 is the global Quality Management Systems Standard used by medical device manufacturers to meet certain requirements to support the safety and effectiveness of the products they sell. Notified Bodies can use this standard when assessing whether companies have a QMS, which meets European Directive requirements. Such an assessment is required where a manufacturer seeks to apply the CE mark. This means that companies must be conversant with ISO EN 13485:2016, the significant aspects of the directives, relevant guidance standards and the CE mark process.

Collapse

What's covered?

Expand/Collapse Expand/Collapse

Day One has a specific focus on the ISO EN 13485:2016 QMS standard and includes;

  • Course Objectives & Introduction
  • Complete Overview of all sections of ISO EN 13485:2016 including a detailed focus on the updates to the standard.

Day Two has a specific focus on the MDD* 93/42/EEC and includes:

  • Parties Involved
  • Key Elements of the MDD* (Articles & Annexes)
  • Guide to the CE Marking Process
  • Medical Device Directive Classification
  • Classification Exercises
  • Conformity Assessment Route Options
  • Linking the ISO EN 13485 requirements to the MDD requirements
  • Proposed upcoming changes to the EU Medical Device Directive
  • CE Marking Exercise

*IVD Directive 98/79/EC can be covered in this course also if there are participants attending from an IVD background.

Who should attend?

Expand/Collapse Expand/Collapse

The course is suitable for personnel from medical device manufacturing industries who need to have a working knowledge of ISO EN 13485 and the MDD. It would be of particular interest to personnel who are required to liaise with notified bodies or need to understand the CE marking process.

What will I learn?

Expand/Collapse Expand/Collapse

Participants achieve the following learning outcomes from the programme;

  • Understand the requirements of ISO EN 13485:2016 including the updates
  • Understand the main requirements of the MDD and have a working knowledge of some of the key Annexes within the MDD.
  • Classify devices according to the MDD
  • Understand the conformity assessment route options
  • Understand all the steps involved in the CE marking process
  • Understand how ISO EN 13485 QMS and the MDD link together (similarities & deficiencies)
  • Be aware of the proposed changes to the Medical Devices Directive
  • Identify the Guidance documents available

Who are the tutors?

Expand/Collapse Expand/Collapse

How do we train and support you?

Expand/Collapse Expand/Collapse

In-House Courses

Course tutor will contact your organisation in advance. In-house courses can be customised to meet your organisation’s specific requirements. Where appropriate, course exercises can be carried out using procedures, data etc from your organisation.

 

Course Manual

Delegates will receive a very comprehensive course manual.

Share this Programme

SnapshotSnapshot

Duration
2 training days
Course Times
9.00am - 5.00pm
Price
€850

(includes course documentation, lunch and refreshments).

Delivery Mode
This programme is available In-House and on certain Public dates

What They SayWhat They Say

The tutor’s knowledge was very high, could relate very well to our company

– Sheila Judge, Account Manager, Trulife Ltd

ISO 13485:2016 & The Medical Devices Directives

Duration: 2 daysPublic Price: €850
Hide