About Introduction to MDR EU 2017/745 Medical Device Regulation
Who can attend this course:
- Managers and Personnel responsible for the CE certification of medical devices
- Regulatory Affairs officer of certification evaluation for medical devices
- Quality Assurance personnel responsible for device and system compliance
- CE certification consultant of medical devices
Course Objectives:
This course enables you to understand the laws associated with the 2017/745 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;
- Analyse of the differences between the regulations of MDD (Medical Devices Directory) and MDR (Medical Devices Regulation)
- Understand the structure of MDR
- Understand essential requirements of MDR.
- Gain knowledge about audit direction and process of Notified Body (NB)
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.
Course agenda:
Day 1:
- Introduction of DNV
- MDR overview and status of transition
- MDD vs. MDR key changes
- Scope of MDR & key definitions
- General responsibility of manufacturers
- Economic operator / UDI
Day 2:
- Conformity assessment module, DOC and sampling criteria
- Classification rules
- Technical documentation
- GSPR (MDR) vs ERC (MDD)
Day 3:
- MDR clinical evaluation process
- MDR Post Market Surveillance and PMCF
- SSCP & PSUR
- Vigilance
- MDR Medical Device Quality Management System
- QUIZ
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.
