This paper looks at key issues and costs drivers in this equation and the industry-driven systems that can help minimize the additional costs associated with the necessary due diligence. It also looks at the choices SigmaTron International, a publicly-traded U.S. EMS provider, has made in developing a compliance system that meets both its needs and […]
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 […]
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.
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 […]
A resource for sample submissions, test descriptions, sample requirements, and turnaround times for biocompatibility testing according to: FDA/ISO 10993 MHLW-Japan USP AAMI