Category Archives: Okategoriserade

Medical Devices Quality Management System Requirements for regulatory purposes Course length 1 day Schedule Each day 08:30 – 16:30 (8.30 a.m. – 4.30 p.m.) Facts   Background ISO 13485 – Requirements for Quality Management System for regulatory purposes Scope The participants will gain knowledge about the ISO 13485 . All basic requirements will be discussed. […]

(Failure Mode and Effects Analysis) Course length 1 day Schedule 08:30 – 16:30 (8.30 a.m. – 4.30 p.m.) Facts   Background FMECA is an important tool to identify potential failures of a product. Through a structured methodology, you will review every aspect of a product design or a product process like manufacturing, warehousing or shipping. […]

ISO 14971 Course length 2 days Facts Each day 08:30 – 16:30 (8.30 a.m. – 4.30 p.m.) Fakta om kursen   Background Risk Management – i.e. the planning, analysis and assessment of risks related to a medical device is a requirement for premarket product approval in for example EU USA and Canada. ISO 14971 replaces […]

Current Good Manufacturing Practice – FDA, USA 21 CFR part 820 Quality System Regulation Course length 1 day Schedule Each day 08:30 – 16:30 (8.30 a.m. – 4.30 p.m.) Facts   Background   For marketing of medical devices in USA, each manufacturer must comply with the requirements of 21 CFR 820 (Quality System Requirements) during […]