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Tag: ISO 13485

Comparing HP 8753 and NanoVNA For Medical Device Design

Medical Devices
This blog compares a traditional Vector Network Analyzer (VNA), the HP 8753, with a NanoVNA for use by the budget constrained engineer developing a...

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...

MDR Extension Timeline for Implementation

Medical Devices
The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends the Medical Device Regulation...

MDR Extension According to Regulation 2023/607

Medical Devices
The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends the Medical Device Regulation...

Free Online Medical Device Development Seminar – Sharpen your skills 2023 – Part 2

Medical Devices
Written by Karl Larsson on 05 September 2023. Posted in Company News. Tuesday September...

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...

Conducting Quality Investigations in Medical Device Manufacturing

Medical Devices
When a quality event, like a product or process nonconformance, occurs in the manufacturing of medical devices, there’s a chance that the safety and...

Auditor shadowing as an effective auditor training technique

Medical Devices
Posted by Rob Packard on July 28, 2023 This article reviews auditor shadowing as an effective auditor training technique, but we also...

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...

CAPA – Corrective Action and Preventative Action

Medical Devices
Posted by Rob Packard on July 18, 2023 What is a CAPA? How do you evaluate the need to open a new...

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...
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