Working with MedTech and life science automatically raises the requirements for accuracy and trustworthiness compared to other fields
In the extremes, it’s a question of life or death. Several EU regulations apply to the documentation of CE-classified MedTech products. At Autotech we have a vast experience of producing such documentation and can guide you on your way.
MedTech and life science are dynamic and rapidly expanding fields in Sweden. The companies starting up are often small or mid-sized and built around a single product. The rules and directives regulating MedTech products are both complex and strict – recently a new EU-directive were put in place (Medical Device Regulation)
Autotech is the perfect partner with consultants having experience from both MTA and leading MedTech companies, allowing you to focus on what you do best – we will take care of the documentation.