The Person Responsible for Regulatory Compliance - The MDR and new responsibilities and challenges for medical device companies
The Person Responsible for Regulatory Compliance - The MDR and new responsibilities and challenges for medical device companies


Dr. iur. Dr. med. Adem Koyuncu

The Person Responsible for Regulatory Compliance - The MDR and new responsibilities and challenges for medical device companies

Seminar

Referent: Dr. Adem Koyuncu


Veranstaltungsseite: | Download Flyer

Sprache: Englisch

Aufrufe gesamt: 10, letzte 30 Tage: 5

Kontakt

Veranstalter

keine Angaben

Preis: 1.090,-- € zzgl. gesetzl. Mwst.

Since the publication of the MDR with the new EU regulatory framework for medical devices, many innovations need to be  implemented. One of them is the person responsible for regulatory compliance (PRRC).

This 'responsible person' has important tasks and responsibilities, which, together with liability risk, will be discussed in detail in this seminar. How must the responsibilities be defined? What are the internal interfaces? What preparation is required for this new role?
Our seminar will address precisely these questions and show you how to make the necessary preparations. Our team of  experts will give you practical tips on how to meet the upcoming challenges and explain the most important issues in practice.

PARTICULAR TOPICS INCLUDE

• Legal and regulatory requirements for the PRRC in Europe

• Interfaces within the company

• Effective preparation and practical challenges

• Audit and compliance readiness

• Liability risk for the PRRC and manufacturer

Dr. Adem Koyuncu

DE, Frankfurt

Partner

Covington & Burling LLP

Publikationen: 40

Veranstaltungen: 38

Aufrufe seit 08/2005: 9037
Aufrufe letzte 30 Tage: 13

Zeitpunkt Veranstaltungsort Beschreibung Kontaktperson  
14.05.2020
Amsterdam
Kontaktanfrage
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