Product design and development is a journey with unexpected twists and turns. People often ask, “how can I make my design process more predictable?” In our 25 years of experience designing medical devices, we’ve found that you can’t always predict all the twists, but there are things that can be done to increase the certainty […]
Combination products: Safety and efficacy considerations of device/drug/biologic interactions
A presentation on Combination Products, which includes the following: Combination Products Definition FDA Guidance for Industry Case Study 1 – Insulin Delivery System Case Study 2 – Antimicrobial Eluting Catheter Technical Risk Assessment Be on the lookout for the video presentation coming shortly.
Micromolding vs. 3-D printing: A White Paper
In this white paper, you’ll learn whether 3D-Printing a model will be sufficient or if a part must be hard-tooled in Micromolding. The advantages of 3D-Printing as a model and prototype-making process have excited the overall product development community. It is natural that the successes experienced by those using 3D-Printing in the “Macro-world” would inspire […]
Medical device testing guide
A resource for sample submissions, test descriptions, sample requirements, and turnaround times for biocompatibility testing according to: FDA/ISO 10993 MHLW-Japan USP AAMI
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