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Medical Device Postmarket Surveillance

Key2Compliance®
1 dag
Kursus
København
7.830 DKK ekskl. moms

Hvorfor vælge Key2Compliance® ?

Markedsleder - Kvalitetsbevidst og med certificeret kompetence

Flere leveringsløsninger og nem adgang til viden - Fleksibilitet

God atmosfære med kooperative og tilgængelig undervisere

Kursusbeskrivelse

medical

Medical Device Postmarket Surveillance (PMS)

During this one day course, you will get a good insight and understanding of the key requirements that shall be fulfilled to establish and maintain a postmarket surveillance system in compliance with EU and US Medical Device regulations.


Course outcome

To get a thorough understanding of the requirements on Postmarket Surveillance (PMS) in MDR and IVDR as well as FDA’s requirements on PMS. Know how to establish and assess the postmarket aspects of your process for measurement, analysis and improvement, according to ISO 13485:2016. Understand the link between risk management, postmarket surveillance and clinical evaluation; especially postmarket clinical follow-up. Learn about requirements on different stakeholders for regulatory reporting as defined in EU and US regulations.


Course description

The course provides practical guidance on how to implement the requirements on Postmarket Surveillance (PMS) in your quality management system and establish a system for proactive and reactive data collection and subsequent data/trend analysis, to identify potential and existing nonconformities. This course outlines the postmarket surveillance process; from the planning phase to implementation and analysis.

The course will touch upon these topics:

  • How to create and update your Postmarket surveillance plan.
  • Analysis and evaluation; trending.
  • Important elements of your quality management system to ensure compliance to PMS regulations.
  • Periodic safety update reports – new PMS reporting requirements under MDR.
  • Relation between PMS, risk management and clinical evaluation.

When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.

Målgruppe

The course is suitable for persons working with quality and/or regulatory for medical devices who is involved in parts of, or responsible for the postmarket surveillance and vigilance reporting for medical devices.

  • You should have basic knowledge of quality systems, e.g. by participating in one of our basic courses or have equivalent knowledge of the company's internal quality assurance programs.
  • You should have at least 6-12 months experience of working in the regulated industry (medical device or pharmaceutical industry).

Pris

Price of this course is 7.830 dkk excl. VAT.

Early bird price: 7.080 dkk excl. VAT.

Om udbyderen

Key2Compliance® er et uafhængigt internationalt netværk, der tilbyder kurser og produkter til forskellige funktioner i Life Science-branchen, fra udvikling til marked med hensyn til kvalitetssystemer og GMP-overholdelse.  Ved at hjælpe organisationer med at imødekomme GMP / QS-forventninger, forbedre arbejdsstyrkens viden...


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Kontaktinfo

Key2Compliance®

Tietgensgade 65
1704

Telefon: +46 (0)8 544 811 60

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