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FDA has issued new draft guidance on cybersecurity for software as a medical device (SaMD). If the FDA releases that draft guidance ‘as is,’ it will massively and negatively...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

How To Apply a Risk-Based Approach to Biological Evaluation

July 1, 2022
No matter where you plan on marketing your medical device, you’ll be required to perform a biological evaluation on your device before you receive regulatory approval. Read More
Product Development

Early Stage Territory Planning for Medical Device Companies

June 29, 2022
Do your field teams still rely on map, spreadsheet, and note apps? How medical device companies have historically generated sales is no longer adequate for selling... Read More
Product Development

Selecting a Notified Body: How to Work with Your New Device Authority

June 26, 2022
Before you can market your product in the European Union, you’ll need a CE marking for your device. And for all but the lowest risk devices (Class I), medical device... Read More
Product Development

4 Letter to File Mistakes That Could Cost You

June 24, 2022
Innovation in medical device technology happens quickly - not only with new product designs, but also with improvements made to existing devices. Read More
Product Development

Regulatory & Quality Perspectives of 3D Printing in the Medical Device Industry

June 22, 2022
What are the differences between 3D printing and additive manufacturing? What are the quality and regulatory considerations around 3D printing? What is FDA’s approach... Read More
Product Development

Ultimate Guide to Software as a Medical Device (SaMD)

June 19, 2022
It’s been more than a decade since Marc Andreesen famously wrote that “software is eating the world.” Since then, software has made its way into practically every industry,... Read More
Product Development

3 Stages of Project Management in the Medical Device Industry & How to Navigate Each

June 17, 2022
Stepping into the role of project manager at a medical device company is a unique and exciting experience. It’s also a challenge, but if you’ve decided to take on this role,... Read More

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