Guide for medical device development and manufacturing
Integrated Electronics Manufacturing Services (EMS) provider Escatec has published a guide to developing, testing and manufacturing medical devices based on its industry experience.
The guide covers how to choose a design partner for faster New Product Introductions (NPIs), the regulatory requirements for medical devices, variations in regulations around the world, and the various stages of design through to volume production.
“The pace of new discoveries in this area keeps accelerating creating new product opportunities and to remain competitive, companies need to move fast to capitalise on them,” said Stefan Beer, Project Manager at Escatec, which has production facilities in the UK, the Czech Republic, Switzerland and Malaysia..
“A recent survey found that MedTech product cycles have become 50% faster over the past five years. However, regulations are becoming stricter to ensure safety and reduce product recalls as, in 2021, reportedly there were 2607 FDA product recalls affecting millions of units and costing manufacturers significant sums. That’s why we wrote this guide, so that companies understand how to launch a new device first and fast with minimal risk but, more importantly, one that is fully compliant with all the various complex regulations,” he said.
The guide is here
The company has been expanding over the past several years with the Group making major investments to acquire the latest technologies and capabilities, as well as significantly expanding its international production and design footprint via acquisition and partnerships for revenues of over $450m this year.
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