๐Ÿ‘‰Registration: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.

15 years of experience in quality assurance and regulation of medical devices,

๐‚๐จ๐ฎ๐ซ๐ฌ๐ž๐ฌ ๐€๐ ๐ž๐ง๐๐š:
26th June 2021, 10h->12h GMT
โœ… Introductions
โœ… Introduction to design control
โœ… Quality system aspects
โœ… Submission aspects (MDR/IVDR/FDA regulations)

3rd July 2021, 10h->12h GMT
โœ… Implementing a top-level design control/ product life cycle procedure
โœ… Use cases

10thJuly 2021, 10h->12h GMT
โœ… Safety and risk management
โœ… Verification and Validation
โœ… Design reviews

17th July 2021, 10h->12h GMT
โœ… Software considerations
โœ… Design transfer
โœ… Change control
โœ… Technical File/Medical Device File/DHF (Design History File)
โœ… Wrap-up

โ€ข Training documents
โ€ข Training certificate

๐Ÿ“ฉ contact@conseilplus.net
๐Ÿ“ž +216 70 830606 / +971 585709967
๐ŸŒ www.conseilplus.net

๐ŸŒ ๐—•๐—น๐—ผ๐—ด ๐—–๐—ผ๐—ป๐˜€๐—ฒ๐—ถ๐—น ๐—ฃ๐—น๐˜‚๐˜€ ๐Ÿ‘‰http://www.conseilplus.net/nos-formations/
๐Ÿ“… Calendrier de nos formations ๐Ÿ‘‰https://lnkd.in/esf3cJc
๐Ÿ“… Nos formations qualifiantes en partenariat avec ๐—ฃ๐—˜๐—–๐—• ๐Ÿ‘‰https://lnkd.in/eAT_3gr



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