Date: 7th of October 2019
Location: The Netherlands, Amsterdam area
Costs: Regular € 875.-
The new EU-MDR brings about
many changes, including many definitions, reclassifications, new conformity
assessment routes, new notified body designations and more. Stricter
requirements on safety of ingredients, on clinical evidence and on consistency
in regulatory compliance. Much more detailing in the essential principles, and
above all: no grandfathering.
The training will discuss
the options available for the transition from MDD to MDR, it will highlight
timelines, resources, Notified Body approach, and the top 10 changes for
technical documentation. This training focusses on practical guidance to
implement the gaps assessments needed for dossiers, QMS and perhaps specific
for clinical. It will provide details on product portfolio review, and on
determining the impact of the regulation. High-level project planning will be
included. The day will be filled with discussions and case studies.
Note: this training can also be provided in-house for
other organizations in the supply chain involved in one or more
stages of the life-cycle of a medical device, including design and development,
production, storage and distribution, installation, servicing or provision of
associated activities. The contents will be adapted to the specific role(s) of
- Perform various gap
assessments at the start of MDR project
- To reflect on the
- Understand how to build and
use assessment lists, tools, and templates
Highlights of transition from MDD to MDR
Strategic options in the transition phase
How to do a
gap assessment of your technical documentation, use of templates and
How to do a gap assessment of your QMS, use of
templates, checklists and management summaries.
How to do a gap assessment of clinical evaluation,
use of templates and checklists.
High-level implementation planning
Questions & Answers
attend this course?
RA manager, RA director, QA manager, QA director,
Clinical Director, Marketing Manager, Sales Manager, international registration