About Introduction to IVDR EU 2017/746 In Vitro Medical Device Regulation
Who can attend this course:
- Managers and Personnel responsible for the CE certification
- Regulatory Affairs officer of certification evaluation for in vitro medical devices
- Quality Assurance personnel responsible for device and system compliance
- CE certification consultant
Course Objectives:
This course enables you to understand the laws associated with the 2017/746 In Vitro Medical Device Regulation and provides you with knowledge required for editing the technical documents for medical device manufacturers.
This course pack is designed to help you to;
- Analyze the differences between the directive of IVDD and the regulation IVDR
- Understand the structure of IVDR
- Understand general safety and performance requirements.
- Gain knowledge about audit direction and process of Notified Body (NB)
Course Leader:
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.
Course agenda:
Day 1:
- IVDR overview and status of transition
- IVDD vs. IVDR key changes
- Scope of IVDR & key definitions
- General responsibility of manufacturers
- Economic operators
- UDI
Day 2:
- Conformity assessment module, DOC and sampling criteria
- Classification rules
- Technical documentation
- GSPR (IVDR) vs ER (IVDD)
Day 3:
- IVDR performance evaluation process
- IVDR Post Market Surveillance and PMPF
- Vigilance
- IVDR Medical Device Quality Management System
- QUIZ
Throughout the chapters and annexes will be covered briefly and some in more detail. There will be exercises along the days.
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.
