For many medical device
companies, processes like risk evaluations, change management, and verification
relies on tribal knowledge. Achieving traceability within your quality system
has historically consisted of days, weeks, or even months spent updating spreadsheets,
and cross-referencing items.
Over time, the complexity
of these quality systems overwhelm teams and creates enormous amounts of stress
and organizational risk.
Current medical device
industry standards and regulations like ISO 13485:2016, FDA 21 CFR Part 820, EU
MDR/IVDR are all moving towards placing a stronger emphasis on the device
maker’s ability to demonstrate closed-loop traceability throughout the Total
Product Lifecycle of a quality system.
Despite this fact, our 2020
State of Medical Device Report revealed that nearly half of all medical device
professionals cannot demonstrate closed-loop traceability (CLT) in their
quality system. Of those that can demonstrate CLT, one in three say it takes
substantial effort to do so.
View the annexures and gain more knowledge
Ajay Bajpai (IMS Lead Auditor/Trainer)
Vice Chairman
TNV Certification Pvt. Ltd.
HO: 537-B/187-B, Amber Vihar, Nr.
CBI,
Keshav Nagar, Sitapur Rd.,
Lucknow-20 UP (India)
Mail: vc@isoindia.org.com /
tnvcpldelhi@gmail.com
web: www.isoindia.org Skype:
ajay.bajpai15 WhatsApp :+9818392734
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