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Product Development

3 Tips for Adding Flexibility to Your MedTech Manufacturing Supply Chain

August 25, 2023
Supply chain management is crucial to any MedTech company’s ability to deliver safe, effective, and high-quality devices to their customers. Read More
Product Development

What is the FDA Medical Device Registration Process?

August 22, 2023
To patients and providers, medical devices are more than a product. They serve as the conduit to better quality of life for patients, improve diagnostic speed and accuracy,... Read More
Product Development

Machine Learning, AI and Risk Management: TIR34971 Explained

August 18, 2023
TIR34971:2023, Application of ISO 14971 to machine learning in artificial intelligence, was published in March 2023. Read More
Establishing a QMS

Conducting Quality Investigations in Medical Device Manufacturing

August 11, 2023
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 efficacy of any affected... Read More
Establishing a QMS

Omnibus Act Impact on Medical Device Cybersecurity

August 7, 2023
The ‘‘Consolidated Appropriations Act, 2023’’ (H.R. 2617) was passed by the U.S. Senate and signed into law by President Biden on December 29, 2022. Read More
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

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