Who we are
en•co•tec® is a consulting company in the south of Vienna – specializing in regulatory affairs and quality management for medical devices and in-vitro diagnostics. With our consulting services and the en.co.tec Academy, we support industry newcomers, start-ups and leading manufacturers and suppliers in the medical device industry.
What we do
At en.co.tec, you can expect individual support and tailored advice:
- Implementing and auditing of quality management systems for manufacturers and suppliers,
- Support with regulatory affairs and compliance with all relevant standards and regulations for medical devices,
- Risk management & many other specialist standards, and
- Lectures and seminars on current topics – such as EU regulations for medical devices & IVD
What we attach particular importance to
We have set ourselves the goal of…
…to prepare the technical, normative and regulatory details associated with medical device approval and quality and risk management for you in such a way that they become simple and transparent and lead to measurable improvements in your business environment.
…to provide you with expert support in advice and training with our knowledge, our many years of experience and our network.
…responding individually to your questions is the basic prerequisite for learning and continuously improving, because we want to be among the best in our field.
…actively participate in the process of training, standardization and legislation and thus help shape the future in our specialist area!
We want to turn you into enthusiastic customers!
