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Establishing a QMS

Understanding ISO 14971 Medical Device Risk Management

May 11, 2023
Medical device companies MUST have established risk management processes that comply with ISO 14971. Read More
Product Development

3 Things to Love about Internal Audits

April 28, 2023
I have a confession to make—I love audits. I mean, I really love audits. Read More
Product Development

eBOM vs mBOM: What’s the Difference?

March 31, 2023
A bill of materials (BOM) contains all the materials and parts required to build your device, as well as directions for how to use them and where to acquire them. Read More
Product Development

How to Handle Medical Device Adverse Events

March 24, 2023
Medical device adverse events can be a daunting challenge for any manufacturer to address. Read More
Product Development

Top 30 MDCG Guidance Documents for Medical Device Companies

March 13, 2023
The Medical Device Coordination Group (MDCG) is a regulatory body made up of industry experts appointed by each of the member states of the European Union. Read More
Product Development

Top 40 IMDRF Technical Documents for Medical Devices

March 10, 2023
The International Medical Device Regulators Forum (IMDRF) is a global organization on a mission—a mission to enhance the safety and quality of medical devices and promote... Read More
Establishing a QMS

Ultimate Guide to Postmarket Surveillance of Medical Devices

February 26, 2023
The pursuit of MedTech Lifecycle Excellence requires that you consider the entire lifecycle of your medical device. This includes systematic monitoring of your device after... Read More
Product Development

7 Essential Steps of a Nonconformance Report

February 24, 2023
Nonconformance is a word no quality manager wants to hear. Read More
Product Development

Beginner's Guide to Design Verification & Design Validation for Medical Devices

February 10, 2023
Design verification and design validation are two essential stages in design controls. It’s easy to confuse the two because they both involve checking an outcome against your... Read More

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