Detail kurzu
Clinical Evaluation and Post Market Surveillance
DNV Business Assurance Slovakia s.r.o.
Popis kurzu
One day course focus on combinating two parts of significant process related to legislative requirements. Overview of clinical evaluation approach, principles and requirements related to new requirements and legislative. An introduction to the PMS process from a regulatory perspective as well as an overview of the process and interfaces.
To give an understanding of the process to run clinical evaluations and how to keep the evaluation up to date during the life cycle of a medical device. PMS process and its understanding, principles and continuity with other processes during whole life cycle of your medical device(s).
Obsah kurzu
The request and requirements on clinical evaluations has increased over the years and it will not become less with the coming new Medical Device Regulation. This part of course will focus on the standards and guidance given, how to make a literature search and plan for clinical evaluation, the report and the feedback system. Requirements on PMS has increased and are incorporated is in the ISO 13485:2016 and the new Medical Device Regulation. This half day course will give an introduction to the regulations and guidance on PMS (plan and report) as well as the process interfaces.
Cílová skupina
Clinical affairs, QA/RA specialists, risk managers, management, design & development engineers, customer support/service and marketing.
DNV GL clients could apply 10% discount
Kontaktní osoba
Sylva Hefnerová
+420 603 575 839
sylva.hefnerova@dnvgl.com
Hodnocení
Organizátor
DNV Business Assurance Slovakia s.r.o.
Sabinovská 8, Bratislava
Spoločnosť zaoberajúca sa nezávislým hodnotením rizík, manažérskych systémov podľa noriem ISO 9001, ISO 14001, ISO 45001, IATF 16949, ISO 27001, ISO 22000, ISO 28000, SA 8000, ISO/TS 22163 (IRIS rev.3), ISO 22301, ISO 31000 a ďalších. Školiace aktivity v oblasti riadenia rizík a manažérskych systémov.
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