Online Training: Quality Management System (QMS) / ISO 13485:2016 Workshop provided by Med-Di-Dia

Online Training

13 June 2022 - 17 June 2022

The Codex4SMEs project provides diagnostics SMEs from North-West Europe with various workshops free of charge, conducted by experts from the network. Med-Di-Dia provides a choice of two different workshops.

Expertise may be provided in small dedicated workshops with 3 SMEs in each. As part of the Codex4SMEs program, Med-Di-Dia offers two optional workshops. An SME can apply for only one of the two workshops. The selection is made on a first-come, first-served basis. The training will only be carried out after three SMEs have registered for the workshop.

There are significant changes in the European legislation applicable to IVDs. The IVDR (In Vitro Diagnostic Regulation) (EU 2017/746) has replaced the IVD Directive (98/79/EC) and will impose new requirements on Legal Manufacturers whose devices will be re-classified (devices higher than Class A) due to the rules associated with these changes.

 

This workshop will include:

  • What is device classification (list of devices and classification code)
  • QMS function and ISO 13485:2016 impact
  • What do clauses 4 to 8 mean within the scope of ISO 13485:2016 and how do they apply
  • Internal Assessments and Notified Body relationships

Quality Management System (QMS) / ISO 13485:2016

Content

Duration

Content

Introduction

25 mins
  • Introduction to Med-Di-Dia
  • Explain the background of classifications
  • Discuss examples of devices that are considered higher than class A
  • Intended purpose - right first time

Part A

45 mins
  • Describe the QMS and the importance of ISO 13485:2016 certification.
  • Role & responsibility of Legal Manufacturer
  • Resources/Cost

Break

10 mins

Break

Part B

45 mins

 
  • Identify the requirements of ISO 13485:2016 by defining the clauses set out from 4 to 8.
  • Discuss the documents relating to the clauses which the Standard is referring to.
  • Understand the importance of documenting changes
  • Explain the importance of technical documentation for compliance
  • Notified Bodies (Friend or foe)
  • Feedback from clients and internal inspections

Exercise or Quiz

30 mins
  • Quiz set up based on info covered already

Break

10 mins

Break

Part C

30 mins
  • FAQs around the QMS

Recap & Finish

15 mins
  • Summary of key takeaways

 1-1 discussion (15 to 30 minutes) can be arranged directly at the end of the Workshop should attendees wish to raise any questions in confidence.  A Confidentiality Agreement can be exchanged ahead of any 1-1 discussion.

About service provider Med-Di-Dia

Med-Di-Dia is a regulatory and quality compliance consultancy firm supporting Medical Device, In-Vitro Diagnostics and Digital Health companies from our base in Galway, Ireland. Med-Di-Dia offers a range of services including:

  • EU Authorised Representative
  • Regulatory Strategy for US, EU and Rest of World
  • Assessments against new EU Medical Device / IVD regulations (2017) to assist with transition to new requirements
  • Device classification & predicate device searches (US)
  • US FDA Regulatory Submissions
  • Clinical evaluations
  • Quality Management Systems
  • Advice, guidance and implementation of all mandatory standards, such as ISO 13485:2016 (Quality Management Systems)
  • Technical file compilation

How to apply for services?

  • Check your eligibility:
    • Does your company meets the SME definition of the EU?
    • Did your SME receive more than a total of €200.000 of de Minimis state aid between 2020 and 2022? For more information about de-minimis aid. You can find helpful information via these links  de minimis rule and state aid.
  • Before you apply, read the full Business Growth Programme description
  • Select only one of the two services provided by Med-Di-Dia you want to apply for by June 3rd, 2022.
  • Complete application form
  • Submit your application and your de minimis self-declaration

Note: The online training is limited to three SMEs. The selection is made on a first-come, first-served basis. The training will only be carried out after three SMEs have registered for it.

 

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