Your need
Your reliable partner when Europe meets the world
Your reliable partner when Europe meets the world
You are a manufacturer of medical devices from a non-EU country and would like to start or continue selling your products in one of the largest economies in the world? We will be your professional partner to handle this challenge as an European Authorised Representative!
Your reliable partner when Europe meets the world
You are a manufacturer of medical devices from a non-EU country and would like to start or continue selling your products in one of the largest economies in the world? We will be your professional partner to handle this challenge as an European Authorised Representative!
We are sure you already know that you have to comply with the requirements as laid out in the ‘Medical Device Regulation’ (EU) 2017/745 or the ‘In-Vitro Diagnostics Regulation’ (EU) 2017/746 and have to designate an authorised representative in order to access the European market with your safe and effective products.
And still, you have not found the right partner, yet? A partner who guides you both professionally and pragmatically through the challenging and seemingly unmanageable jungle of regulatory and technical requirements? A partner who also supports you in meeting these requirements and implementing the necessary design adoptions?
Well, now you are on a good track, as you have found us! Let us be your ‘Authorised Representative’ as required per article 11 in both regulation (EU) 2017/745 and (EU) 2017/746.
Who are we and what drives us? – the qtec group is an essential partner of medical device manufacturers, located in Germany. Under the qtec group family the qtec services GmbH as universal provider for Regulatory Affairs, Design Control and Quality Management services and the qtec EuRep GmbH as authorised representative for medical devices and in-vitro diagnostics are closely related to each other.
The well-being of the patient is our top priority. It fulfills us that with the help of our work, your products will be made available for patients safely, effectively and in time. Even if we do not develop, manufacture or sell medical devices ourselves, we are experts in ‘medical devices’ as we constantly gain distinctive knowledge while we continuously support medical device manufacturers all over the world without being your competitor.
Our vision „Your reliable partner when Europe meets the world“ determines our actions.
As we have more than 85 experts at the qtec group collaborating closely together, we have the distinct knowledge to answer every conceivable question and master every conceivable task on the way to a safe medical device and its successful placing on the EU market.
As your strategic partner at hand, we assure that you as a manufacturer from outside of the EU, may start or continue selling your products. In order to make sure that you comply with the requirements as laid out in the MDR (MDD) and IVDR (IVD) we
- Position ourselves as a communication and coordination interface between you and your notified body or any competent authority in case of vigilance activities, CAPAs, complaints, or any clarification needs.
- Check your EU declaration of conformity
- Check your technical documentation and have available a copy of it,
as required by MDR and IVDR - Check your conformity assessment procedure and support you on your way, to guarantee a smooth registration procedure
- Support you with labeling requirements
And for the unlikely event that corrections are needed to your documentation or your product, we have the experts at hand to fix it!
Don`t wait any longer, get in touch with us!
qtec Academy
Focused on your training
Our interactive training courses turn your training into an experience. With application-oriented training courses and workshops, we work with you to develop customized solutions to meet your challenges.
Whether you choose an in-house training session or an external seminar, our comprehensive portfolio covers a wide range of topics to make sure you find the training option you are looking for.
Latest News
about the European market
On our qtec Group website, you will find exciting articles on current topics and expert opinions. Immerse yourself in our wide range of articles.
Common Criteria for Information Technology
Security Evaluation
Common Criteria (CC): International IT security standards for medical devices, supported by BSI and BfArM, enhance cybersecurity and trust in processes.
Impact of the MDR on Quality Assurance Agreements (QAA)
We will show you why a quality assurance agreement is an important and central document of the MDR, and should make sure it is always up to date.
Person Responsible - Implementation of Article 15 MDR
As a partner in medical technology, our experts will assume the function of an external responsible person for your company if required.
Latest News
about the European market
Here you will find exciting articles on current topics and expert opinions. Immerse yourself in our wide range of articles.
Free webinar: Clinical Data for PMCF
In our free qompakt webinar series, our speakers impart bundled specialist knowledge and share their practical experience. The Question & Answer session at the end of each webinar block is particularly popular.
Demands for Swiss medical device manufacturers
The requirements for Swiss medical device manufacturers have changed; the qtec EuRep team will tell you what you and your company need to be aware of.
Authorized Representative – A vital partner for market access
Authorized Representative – what you should expect from this key access to the market.
Free webinar: Clinical Data for PMCF
In our free qompakt webinar series, our speakers impart bundled specialist knowledge and share their practical experience. The Question & Answer session at the end of each webinar block is particularly popular.
Demands for Swiss medical device manufacturers
The requirements for Swiss medical device manufacturers have changed; the qtec EuRep team will tell you what you and your company need to be aware of.
Authorized Representative – A vital partner for market access
Authorized Representative – what you should expect from this key access to the market.