Design Controls 101 and Implementation Best Practices - Galen Data скачать в хорошем качестве

Design Controls 101 and Implementation Best Practices - Galen Data

WEBINAR 24 | Design Controls 101 and Implementation Best Practices | Galen Data For many, Design Controls is still a topic that is as confusing today as it was when the FDA first introduced 21 CFR Part 820. In addition, it is not uncommon to hear negative conversations regarding Design Control processes, yet Design Controls are not just required by the FDA – they are a necessity to be a prudent product developer. Design controls demonstrate our medical devices are safe, effective, and meet the indications for use. This webinar will dive into what Design Controls are, how to address them, and how they benefit your medical device product development efforts. ✔️ Discussion Topics: Requirements for different medical device classes Overview and practical application of FDA Design Controls 820.30 The relationship between risk management and design controls Practical applications and tips to assist in documenting design controls ✔️ About our Speaker: Our guest, Laura Court, is a Medical Device “Guru” at Greenlight Guru. For the past year, Laura has helped over 100 companies implement their eQMS including advising on Design Controls best practices. Before coming to Greenlight Guru, Laura spent time in the medical device industry as a product development engineer, managing products through full product lifecycle into post-market support. ✔️ Contact Galen Data for your healthcare connectivity needs: 👉 https://www.galendata.com/contact/ 0:00 Introduction 0:05 GALEN DATA MEDICAL DEVICE INNOVATION WEBINAR SERIES 0:46 Galen Cloud Secure, Compliant, Turkey Cloud Connectivity Platform 2:03 MEDICAL DEVICE QUALITY IS ALL WE DO AND WE'RE ALWAYS AHEAD OF THE GAME. 4:23 FDA Classifications 11:55 FDA DESIGN CONTROLS 820.30 12:08 820.30(B) DESIGN PLANNING 15:56 820.30(C) DESIGN INPUTS 22:33 820.30(D) DESIGN OUTPUTS 24:58 820.30(E) DESIGN REVIEW 30:49 820.30(F) DESIGN VERIFICATION 35:04 820.30(G) DESIGN VALIDATION 38:12 820.30(H) DESIGN TRANSFER 40:30 820.30(1) DESIGN CHANGES 42:41 820.30(J) DESIGN HISTORY FILE 45:01 Risk Management & Design Controls 46:14 RISK MANAGEMENT + DESIGN CONTROLS 47:36 RISK-BASED QMS 54:24 Galen Cloud Features and Benefits