๐Registration:ย https://lnkd.in/eyBh3_5
Date: June 26, July 03, 10 and 17, 20
In depth understanding of design controls for medical devices and In
vitro medical devices. The training explains how to comply with the international quality management system standard ISO13485:2016 product realization process, FDA design controls quality system regulations, and the European MDR / IVDR regulations.
๐๐ซ๐๐ข๐ง๐๐ซ:
15 years of experience in quality assurance and regulation of medical devices,
๐๐จ๐ฎ๐ซ๐ฌ๐๐ฌ ๐๐ ๐๐ง๐๐:
26th June 2021, 10h->12h GMT
โ
Introductions
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Introduction to design control
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Quality system aspects
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Submission aspects (MDR/IVDR/FDA regulations)
3rd July 2021, 10h->12h GMT
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Implementing a top-level design control/ product life cycle procedure
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Use cases
10thJuly 2021, 10h->12h GMT
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Safety and risk management
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Verification and Validation
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Design reviews
17th July 2021, 10h->12h GMT
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Software considerations
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Design transfer
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Change control
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Technical File/Medical Device File/DHF (Design History File)
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Wrap-up
Deliverables:
โข Training documents
โข Training certificate
๐ฉ contact@conseilplus.net
๐ +216 70 830606 / +971 585709967
๐ www.conseilplus.net
๐ ๐๐น๐ผ๐ด ๐๐ผ๐ป๐๐ฒ๐ถ๐น ๐ฃ๐น๐๐ ๐http://www.conseilplus.net/nos-formations/
๐
Calendrier de nos formations ๐https://lnkd.in/esf3cJc
๐
Nos formations qualifiantes en partenariat avec ๐ฃ๐๐๐ ๐https://lnkd.in/eAT_3gr
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