Support to transfer your concepts and prototypes from TRL3-5 to TRL7-9

Description

With our Regulatory Affairs team we can support to transfer your concepts and prototypes from TRL3-5 to TRL7-9. Activities here include, but are not limitd to full-fledged Risk Management and Usability Evaluation. All activities are strictly following our ISO 13485 certified Quality Management System which allows to integrate our activities directly into the Technical Documentation of the new device which supports fast track to certification.

This is a service of

ACMIT Gmbh

https://www.acmit.at
Viktor Kaplan-Straße 2/1, 2700 Wiener Neustadt, Austria
Incorporated Entity

Service url: https://www.acmit.at
Typical users: This service is available and useful for many user groups, but might be mainly of interest for academic partners and start-ups in order to translate concepts and prototypes into setups with TRL7-9 with particular consideration of regulatory requirements.
Financial modal: Paid, co-funded by a third party
Limit: No
Region: Global
Developed for H2020 EIT or another EU project: No
Operational since: 2015

Service category

Certification and Go-to-Market Services
- Product certification support for EU and non-EU markets such as CE, FDA, FCC compliance