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Post-Market Surveillance

How to Comply with HIPAA and EU GDPR in Medical Device Studies

August 17, 2023
The U.N. recognizes privacy as a fundamental human right, and nowhere is this more important than in medical data. That’s why both the US and the EU have regulations in place... 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
Regulatory Submission

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
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

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