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HIGHLIGHTS
"The NEW CE MARKING"
Get your questions answered for the NEW REGULATION
– THE MDR/IVDR!!!

more...


In-House Workshops
"The NEW CE MARKING"
Book now
to make sure you’re ready to survive and thrive!


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Cosmetic Products in Europe

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EVENTS
Join us!

MDSS Roadshow
- "The NEW CE MARKING” 



*Eligible for a total of 6 RAC credits



Meet us!


AACC Clinical Lab Expo
July 31-02 August, 2018
Chicago, USA
Booth #4052

RAPS
October 01-04, 2018
Vancouver, BC, Canada
Booth #307




Contact MDSS

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

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contact us





In-House Workshops - "The NEW CE MARKING"



Medical Device Safety Service is now offering In-House Workshops!

Throughout the year, MDSS organizes events to provide learning opportunities to our clients. Given the new medical regulations that are coming into place, it is more important than ever to provide our clients with all relevant information to enable them to cope with the new regulations.




Train your whole team with our tailor-made workshops!




Benefits for the company:
  • Workshop will be develop according to your needs
  • Presentation will be structured to answer specific questions
  • Reduce costs of travel and accommodations (we come to you!)
  • Convenient since you pick the date of the workshop1
  • Allowance of maximal number of participation2
  • Guidance of new regulations for key persons
1Please provide us with two dates to choose from.
2The company must provide the conference room according to the number of participants.



Cost:    $3500.00 (US Dollars)
3

3 Cost for 1 day workshop including all expenses (e.g. workshop, travelling, accommodation).
If you are interested in more than a 1 day workshop, please contact us and we will work with you a more cost-efficient price.



MDSS Requirements:
  • A projector and screen for the designated conference room
  • 50 % deposit upon agreement of date
  • Once flight has been booked, deposit is non-refundable


Suggested topics for a 2 days Workshop: 

  • The new regulatory system – an overview
  • Economic Operators (Manufacturer, Authorized Representative, Importer and Distributors) Scope and definitions (Chapter I, II, Annex XVI)
  • Classification, Conformity Assessment and Quality System requirements (Chapter V, Annex VIII (Classification) and IX to XI (Conformity Assessment)) Application on High-Risk class product!
  • Notified body and Certificates issued by notified bodies, CE Marking of conformity and Declaration of Conformity (Chapter IV, Annex IV, V, VII, XII).
  • Post-Market surveillance (PMS), Vigilance and Market Surveillance (Chapter VII, Annex III).
  • Member states cooperation, Medical Device Coordination Group, Experts laboratories, Experts Panels, Eudamed and UDI (Chapter III, VIII, Annex V)
  • Technical Documentation, Clinical Evaluation, Clinical Investigation Post-Market Clinical follow up (PMCF) (Chapter VI, Annex I, XIV, XV)
  • Timeline for implementation, New legal aspects, Other aspects (Chapter II, X)


Suggested topics for a 1 day Workshop: 

For a one day workshop, 4 topics should be selected. We suggest the overview, the economic operator, PMS/vigilance and the timeline with other important aspects.
However, if requested specific questions from all areas may be raised beforehand and will be addressed.  


Book now to make sure you’re ready to survive and thrive!



Please contact us for further information, we will immediately provide further details.


Your MDSS Team