DNV GL Česká republika

Clinical Evaluation and Post Market Surveillance

One day course focus on combinating twa 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.

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Lubomíra Zachová

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Clinical Evaluation and Post Market Surveillance training DNV GL

Training Information

  • Rozsah kurzu:

    1 day

  • Informace pro zájemce:

    600,- € excluding VAT. DNV GL clients could apply 10% discount.

Background


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 andguidance 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.


Intended for:


Clinical QA/RA specialists, risk managers, management, design&development engineers, customer support/service and marketing.

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) commitee and was also part of the international PMS task force.

Language:


Course material is in English, presentation in English

Time:


7th Semptember 2018


Location:


DNV GL Busimess Assurance Czech Republic s.r.o., Thákurova 4, 1 60 00 Praque 6/ Hotel Diplomat

Price:


600,- € excluding VAT. DNV GL clients could apply 10% discount.

Registration:


You can register on e-mail address: sylva.hefnerova@dnvgl.com or +420 603 575 839