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Product Development

How to Improve Detecting, Correcting, and Preventing Nonconformances

July 17, 2023
If you work at a MedTech company, nonconformances are a fact of life. As long as there is still a human element in the development and manufacture of medical devices, there... Read More
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
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
Product Development

How to Develop a Risk-Based Approach to Supplier Management

June 18, 2023
The goal of your MedTech company’s supplier management process should be to ensure a consistent supply of high-quality parts and components that conform to your... Read More
Product Development

How to Manage Complex Downstream Design Changes to Your Medical Device

June 11, 2023
It would be nice if every device your company ever produced got to remain on the market for decades, completely unchanged. Read More
Product Development

CSV vs. CSA: Exploring FDA’s New Software Validation Approach

June 4, 2023
In September of 2022, FDA issued a new draft guidance on software validation: Computer Software Assurance for Production and Quality System Software. Read More
Establishing a QMS

Making the Business Case for an eQMS Solution for Your Company

June 2, 2023
As a MedTech Quality professional, you know that you need an eQMS solution. Working in a legacy or paper-based system can significantly impact your team’s overall speed and... Read More
Product Development

Managing Major Changes to Medical Device Packaging

May 29, 2023
Charles Darwin famously said, “It is not the strongest of the species that survives, nor the most intelligent that survives. It is the one that is most adaptable to change.”... Read More

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