Gearoid Kerins

Three-Phase Design Transfer Process to Prepare a Design for Manufacturing

by Gearoid Kerins
Design transfer is a phrase that describes the activities and processes that introduce a medical device design to production. Effective design transfer is required by regulators but it also keeps manufacturing costs under control and ensures production milestones and deadlines are met. Furthermore, effective design transfer can reduce time to market and improve product quality. What is involved in the design transfer process and what are the requirements? At Arrotek, we have a Three-Phase Design Transfer process to prepare a design for commercial manufacturing. The final phase involves a comprehensive checklist that is important for the process itself as well as...

Bottlenecks, Timelines, and Complexity: Overcoming EU MDR Challenges

by Gearoid Kerins
It is now over a year since the new EU Medical Device Regulation (MDR) came into effect. Whether you are an early-stage start-up, a company further advanced in your start-up journey, or an established medical device company, what are the current realities of EU MDR compliance? The fact is, there are challenges that will impact just about every medical device company operating or planning to operate in the EU. Before we get into those challenges, though, a quick recap of where we are. Fast-Approaching Deadlines All new medical devices seeking approval for the European market must now go through the...