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Establishing a QMS

Ultimate List of ISO Standards for Medical Devices

July 14, 2023
The International Standardization Organization (ISO) is an independent, non-governmental organization that has created thousands of international standards for numerous... Read More
MedTech Lifecycle Excellence

The Role of dFMEA in Risk Management for Medical Devices

July 12, 2023
How do dFMEA and ISO 14971 work together? This topic is controversial but essential, and today’s guest is more than capable of tackling it. Risk management is one of the top... Read More
MedTech Lifecycle Excellence

Understanding the ROI of an eQMS

July 11, 2023
In this episode with Fran Cruz, Chief Customer Officer at Greenlight Guru, we explore the investment of a purpose-built electronic Quality Management System (eQMS). Read More
MedTech Lifecycle Excellence

CSA vs. CSV: Modern Validation for Modern MedTech

July 7, 2023
In this episode, Sandra Rodriguez, an analyst at Axendia, dives deep into the complexities of Computer Systems Validation (CSV) versus Computer Software Assurance (CSA) in... Read More
Establishing a QMS

eQMS Buyer’s Guide: Making the Business Case for a New QMS Solution

July 6, 2023
You know you need a new QMS solution. You may even have your sights set on an eQMS that you’ve evaluated and believe is the best option for your organization. Read More
Product Development

Identifying and Evaluating Medical Device Importers

July 3, 2023
Expanding into new foreign markets is an exciting chapter for any medical device manufacturer. Read More
Clinical Data Collection

Writing a Clinical Investigation Plan (CIP): The Essential Guide

June 30, 2023
A clinical investigation plan (CIP) is an essential part of any medical device clinical trial. The CIP is a standalone document that includes everything investigators and... Read More
MedTech Lifecycle Excellence

Management Responsibility: The most important part of a QMS

June 29, 2023
Management responsibility is crucial to the success of a QMS… but what is it? What’s covered by the topic of management responsibility and who’s the responsible party? In... Read More
Establishing a QMS

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

June 25, 2023
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... Read More

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