MDR Workshop from the Producer Perspective

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MDR Workshop from the Producer Perspective

Ladies and Gentlemen,
We cordially invite you to take part in the first practical workshop for medical device manufacturers organized by Technomed in cooperation with CeCert, which will take place on March 17 from 9:00 a.m. to 2:30 p.m.
During them, the main emphasis will be placed on preparation for the new requirements in the case of the production of class 1 medical devices, because this part of the market must adapt to the new legal order as soon as possible. & Nbsp;
During the workshop, experts will discuss the following issues for you:

  1. Starting MDR
  2. Manufacturers responsibilities
  3. Registration of producers and products
  4. Clinical assessment
  5. Compliance assessment and documentation, including risk analysis
  6. Post-marketing surveillance
  7. Observation
  8. Red flag report – where to start MDR preparation

Speakers :
Aleksandra Rodatus-Gil

He has been dealing with medical devices for over 15 years. Initially as a quality representative and constructor, now as an employee in the Supervision Department of URPLWMiPB and a member of the Product Coordination Group
Katarzyna Herka
For many years associated with quality management systems. Practitioner in the field of conformity assessment of medical devices and implementation of quality assurance systems. Auditor in the field of ISO 9001, ISO 13485, ISO 14001
dr Michał Pachowski
President of CeCert certification body, which has PCA accreditation in the area of ​​quality certification, ERCA accreditation in the area of ​​selected training. The company is in the process of obtaining notification in the field of medical devices

Technomed members – free participation. The cost for a non-affiliated company is 400 PLN for 1 person, 3-person discounts. 10%. If you are interested, please register by e-mail at biuro@technomed.org.pl

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