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Tag: ISO 14971

Similarities and Differences between Medical Device 510(k) and CE Marking

Medical Devices
This article highlights some of the similarities and differences between the Medical Device 510(k) and CE Marking regulatory pathways and helps harmonise some aspects...

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Hiring an Auditor

Medical Devices
In this article, you will learn how to hire an auditor to conduct medical device internal audits and supplier audits. Hiring an auditor, whether...

Design Controls Implementation

Medical Devices
Posted by Rob Packard on August 30, 2023 Design controls can be overwhelming, but you can learn the process using this step-by-step...

Machine Learning, AI and Risk Management: TIR34971 Explained

Medical Devices
TIR34971:2023, Application of ISO 14971 to machine learning in artificial intelligence, was published in March 2023. The technical report is a response to the AI...

Look Before you Lead: Planning for Summative / Human Factors Validation Testing

Medical Devices
Human factors validation testing is the final usability testing to be completed prior to regulatory submission. A mistake or an omission may result in...

Seven ways to improve quality auditor training

Medical Devices
Posted by Rob Packard on July 26, 2023 A five-day lead auditor course is never enough. Effective quality auditor training must include...

How do you demonstrate training competence?

Medical Devices
Posted by Rob Packard on July 11, 2023 Anyone can sign and date training records, but how do you demonstrate the effectiveness...

15 Questions to Ask QMS Software Vendors in the Medical Device Industry

Medical Devices
As a medical device company, you are expected to deliver innovative, life-changing medical device(s) while ensuring compliance and achieving true quality. This task bears...

Clinical Investigation Plan (CIP): The Essential Guide

Medical Devices
A clinical investigation plan (CIP) is an essential part of any medical device clinical trial. The CIP is a standalone document that includes...

Nine easy ways to organize and improve quality system procedures

Medical Devices
Posted by Rob Packard on March 28, 2023 Would you like to learn nine ways to improve your quality system procedures? One...

Why modernize 21 CFR 820 to ISO 13485?

Medical Devices
Posted by Rob Packard on January 10, 2023 The FDA patches the regulations with guidance documents, but there is a desperate need...

Vivalink boost Biometrics Data platform for clinical trials and healthcare

IOT
Campbell, United States – Vivalink, a provider of digital healthcare solutions, announces physiological data from a wide range of the wearable technology are available with...

Auditing Risk Management Files

Medical Devices
Posted by Rob Packard on November 1, 2022 What do you look at and look for when you are auditing risk management...
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