his course will give an overview of the standard, the process and the tools. With expectations from Notified Bodies and authorities also being discussed. The process interface and the resource needs will be part of the course along side a workshop on risk analysis. The ISO/TR 24971 will also be covered.
DEL:
About Risk Management - ISO 14971:2019
Risk Management – i.e. the planning, analysis and assessment of risks related to a medical device is a requirement in MDR and for premarket product approval in for example EU USA and Canada.
Goal:
To give a basic understanding and give some tools on how to run and benefit from the risk management process.
Who benefits:
Management, design and development engineers, QA/RA specialists, risk managers, customer support/service, clinical support, marketing, contract manufacturer and component manufacturer as applicable.
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).
Program:
Introduction to the ISO 14971
• Background and regulatory requests
• The risk management process
- Risk Management Plan (RMP)
- Acceptance criteria
- Risk Analysis
- Risk Management Report
• Process interfaces and organization requirements
Risk analysis
• What kind of risk analysis and technique?
• Work shop RMP and risk analysis
• Presentation work shop
Discussion and questions
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.
