𝐈𝐒𝐎 𝟏𝟑𝟒𝟖𝟓:𝟐𝟎𝟏𝟔 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐩𝐫𝐨𝐝𝐮𝐜𝐭 𝐫𝐞𝐚𝐥𝐢𝐳𝐚𝐭𝐢𝐨𝐧 /𝐅𝐃𝐀 𝐝𝐞𝐬𝐢𝐠𝐧 𝐜𝐨𝐧𝐭𝐫𝐨𝐥𝐬

👉Registration: 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.

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

𝐂𝐨𝐮𝐫𝐬𝐞𝐬 𝐀𝐠𝐞𝐧𝐝𝐚:
26th June 2021, 10h->12h GMT
✅ Introductions
✅ Introduction to design control
✅ Quality system aspects
✅ Submission aspects (MDR/IVDR/FDA regulations)

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

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

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

Deliverables:
• Training documents
• Training certificate

📩 contact@conseilplus.net
📞 +216 70 830606 / +971 585709967
🌐 www.conseilplus.net

🌐 𝗕𝗹𝗼𝗴 𝗖𝗼𝗻𝘀𝗲𝗶𝗹 𝗣𝗹𝘂𝘀 👉http://www.conseilplus.net/nos-formations/
📅 Calendrier de nos formations 👉https://lnkd.in/esf3cJc
📅 Nos formations qualifiantes en partenariat avec 𝗣𝗘𝗖𝗕 👉https://lnkd.in/eAT_3gr