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FDA has issued new draft guidance on cybersecurity for software as a medical device (SaMD). If the FDA releases that draft guidance ‘as is,’ it will massively and negatively...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

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

Approaching Cybersecurity & Usability as a SaMD Company

May 27, 2022
How do you balance security and usability of software as a medical device (SaMD)? It’s not easy and trade-offs may need to be made by device companies in order to give... Read More
Product Development

How to Build a Medical Device Business Case in 5 Easy Steps

May 16, 2022
In business, so much of success depends on timing. A product launches too early and is misunderstood by the market; a product launches too late and becomes another face in... Read More
Product Development

8 Questions That Define Your Medical Device User Needs

May 6, 2022
When people talk about design controls, they often place a lot of emphasis on design inputs and outputs, verification, transfer, and the design history file. Read More
Product Development

3 Common Misconceptions About Medical Device Packaging

April 8, 2022
If you asked people what comes to mind when you say designing a medical device, you’re likely going to have responses related to design controls or the device itself. What... Read More

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