Compliance with European regulations has become progressively more complex, especially with the publication of the EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746).
DEL:
With the new regulations, European regulators want to make sure companies always have a qualified regulatory expert at their disposal to ensure the company is meeting EU requirements.
Thus, a new role has been created called the Person Responsible for Regulatory Compliance (PRRC) referred to in Article 15 of the European MDR and IVDR.
About Person Responsible for Regulatory Compliance (PRRC)
What will you learn:
In this 1 day training you will learn what you need to know about the role as PRRC, which is mandatory for Medical and In Vitro Diagnostic Device Manufacturers. We will get knowledge of what the role covers and how this role should be implemented from a regulatory perspective. The course is aimed at individuals appointed PRRC or for economic operators that need a PRRC.
Content of the course:
- MDR/IVDR requirements for PRRC
- What does PRRC mean to the organizations throughout the medical device lifecycle including economic operators
- What are the qualifications needed
- What is the responsibility and authority
- How shall outsourcing of the role be managed
- What is the job description and work tasks according to the MDR/IVDR
- How to understand MDCG guidance and other guidance documents
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Course Leader:
Anette Sjögren, PREVENTIA AB
Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force.
Language:
Course material is in English.
Presentation in English or Swedish (depending on the participants).
Med mere end 70.000 certifikater udstedt på verdensplan, har DNV GL i årevis været den foretrukne certificeringspartner for mange internationale organisationer samt mindre og mellemstore virksomheder.
DNV GL's lokale tilstedeværelse, globale erfaring og anerkendte faglige kompetence på tværs af brancher bidrager til et godt samarbejde med vores kunder. Vi samarbejder med vores kunder for at hjælpe dem med at skabe værdi, og til at opfylde økonomiske, sociale og miljømæssige krav og udfordringer - uanset industri, branche eller størrelse på organisationen.
Gennem vores certificering, verificering, assessments og kursus ydelser, styrker vi vores kunders organisationer, produkter, medarbejdere, faciliteter og forsyningskæder.
Vores kerneområder er:
* Certificering af ledelsessystemer - Vi har udstedt mere end 70.000 certifikater.
* Supply Chain Management
* Produktcertificering - Sikre adgang til globale markeder og mere bæredygtige produkter.
* Verifikation
* Personcertificering- Sikre og skabe tillid til individuelle kompetencer.
* Uddannelse – Inden for kvalitet, miljø, arbejdsmiljø og audit
Vores mission er at beskytte liv, ejendom og miljø, da DNV GL gerne vil bidrage til en sikker og bærerdygtig fremtid.
