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Product Development

Integrating Connected Device Data into Your Clinical Study

July 26, 2022
Connected devices are devices that may or may not be approved/cleared medical devices. They can be used in multiple places, e.g., a device that is under investigation itself,... Read More
Product Development

Downstream Effects of Inadequate Complaint Handling

July 24, 2022
Getting a product to market is the number one goal of any MedTech startup. But the job isn’t over once that product is on the market—it’s just the beginning. Read More
Establishing a QMS

Greenlight Guru Further Extends Commitment to Quality for Customers with Earning Both ISO 9001 and ISO 27001 Certifications

July 21, 2022
The certifications for a Quality Management System and an Information Security Management System provide third-party validation of Greenlight Guru’s operating system and... Read More
Product Development

Guerilla Tactics for Quality Leadership

July 20, 2022
What are guerilla tactics for quality leadership? How do you implement a lean quality management system (QMS) and put requirements in place that are truly required -... Read More
Product Development

Preventing the Death of Medical Device Sales

July 13, 2022
The medical device sales industry is slow to change. It’s behind on how hospitals and physicians adopt and adapt to buying, sales strategies are out of date, and... Read More
Product Development

5 Signs Your MedTech Startup is Ready for the Next Round of Funding

July 10, 2022
Medical device startups are one of the greatest sources of inspiration in the MedTech industry. Read More
Product Development

Purpose-Built QMS vs General-Purpose QMS: What You Can Expect From Each

July 8, 2022
Just like the tools at your local hardware store, quality management software comes in many shapes and sizes. Read More
Product Development

Shifting Sands of SaMD Cybersecurity Regulations

July 5, 2022
FDA has issued new draft guidance on cybersecurity for software as a medical device (SaMD). If the FDA releases that draft guidance ‘as is,’ it will massively and negatively... Read More
Product Development

Understanding The Relationship Between Usability and Labeling of Your Medical Device

July 3, 2022
Though they span a huge spectrum of applications, all medical devices are created for the same purpose: to improve the quality of life for their users. Read More

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