We are delighted that since the company was founded in 2000, we have been able to support a wide variety of customers from the medical technology sector, medical universities and technical colleges, laboratories, and various companies from other industries in more than 190 consulting projects and numerous in-house seminars, online courses, and open seminars.
We are always very grateful for feedback! Read for yourself what some of our customers say about us.
In-house training: ISO 13485 basic course
We recently had en.co.tec delivering an in-house ISO 13485 training, and we couldn’t be more satisfied with the experience. Here are some highlights that made this training exceptional:
- Perfectly organized and customized: The training was meticulously planned and tailored to meet our specific needs. The evaluation test at the end was well-balanced, being neither too challenging nor too easy for the participants.
- Super engaging, highly experienced trainer: Mr. Schmid was always eager to answer questions, especially those related to our current business operations. Open discussions among the participants were effectively moderated, making the learning process engaging and relevant.
- Effective training approach: The training seamlessly alternated between built-in exercises and lecture time, which significantly enhanced the efficiency and engagement of the participants.
- Tailored training materials: The training materials were perfectly adapted to the context of our business, making the learning experience more applicable to our daily operations.
- Swift processing: The tests, test results, and certificates were processed and delivered very swiftly, demonstrating the professionalism and efficiency of en.co.tec.
Overall, I highly recommend en.co.tec for in-house training. Their expertise, organization, and dedication to meeting client needs have made a significant positive impact on our team.
Thank you, en.co.tec!
IN-HOUSE TRAINING:
Fundamentals and Practical Implementation: MDR, German Medical Device Regulations, EN 62353, and EN 60601-1 (2025)
We had the pleasure of supporting Arthrex GmbH in the summer of 2024 with a 2.5-day in-house training session in Odelzhausen near Munich, and we are delighted with the excellent feedback we received:
What both the participants and I, as the person responsible for the training, especially appreciated was that, despite the wide variety of topics everything could be discussed thoroughly and in detail. Many thanks for these great training days!
CONSULTING – INTERNAL AUDITS
Partnering with en.co.tec Schmid KG was instrumental in our success. Their deep expertise in medical device software regulations, especially for AI-driven solutions, gave us confidence at every step. We couldn’t have achieved our market launch so efficiently without their support. The independent internal audits conducted by the certified auditors of en.co.tec Schmid KG have been very thorough and insightful. Their recommendations not only helped us prepare for the 3rd party audits with the notified body, be it surveillance or recertification audits but also enhanced our internal quality management system for long-term success.
Most importantly, their comprehensive regulatory consultancy services provided us with the right direction to focus on innovation while we ensure compliance and accelerate market entry.
Internes Audit nach ISO 13485:2016
The internal audit that we conducted with en.co.tec was a complete success in every respect. From the professional preparation to the detailed execution—Mr. Schmid impressed us with his in-depth expertise, pragmatic solutions, and a clear, structured approach.
Thanks to his expertise, we were able to identify weaknesses at an early stage and implement sustainable improvements. We feel optimally prepared for the future and would like to thank en.co.tec for their valuable support.
ISO 13485 & MDR Certification
“With the support of encotec, FotoFinder has successfully achieved MDR certification. Martin Schmid and his team impress with their expertise and pragmatic approach, consistently managing to explain complex subject matter in an accessible and understandable way.”
IN-HOUSE SEMINAR: “REQUIREMENTS FOR ACTIVE MEDICAL DEVICES”
We were looking for a 3-day in-house seminar series on the topic of “Requirements for Active Medical Devices” and have come across en.co.tec.
And are completely satisfied!
Organisationally, everything went very smoothly and our wishes from the preliminary discussions were implemented optimally.
The trainers’ expertise was very high, so none of the participants’ questions remained unanswered.
We will therefore be happy to recommend en.co.tec to others!
ONLINE-LEHRGANG:
REGULATORY EXPERT for Medical Devices and IVD (In Vitro Diagnostics)
en.co.tec has a very coherent training concept, which certainly demands a lot from the participants, but is definitely manageable thanks to the excellent mix of practice and theory combined with outstandingly qualified trainers.
A big compliment for both the content-related and organizational execution of the seminars in the area of Regulatory Expert MDR/IVDR.
Through this training, I have gained very important new insights as well as different perspectives, which will certainly help me to make future Regulatory Affairs projects more successful.
I can recommend this training to anyone involved in complex projects who wants to broaden their horizons.
The exchange with colleagues from other companies who have to tackle similar tasks, as well as the excellent mix of theory and practice and the engagingly presented scientific know-how, were very beneficial.
IMPLEMENTATION & CERTIFICATION ISO 13485
The entire biocrates life sciences team is proud to have successfully completed ISO 13485 certification.
We are grateful for the professional support provided by en.co.tec in the demanding regulatory IVD environment.
With this certification, we have laid another important foundation for our future development.
SEMINARS
For ACMIT as a development and manufacturing service provider in the field of medical devices, it is essential to always stay up to date with regulatory requirements.
The course offerings from en.co.tec help us a lot with this.
SEMINAR: New IVD Regulation
Due to the new IVD Regulation, we organized an internal basic training for our employees in February 2021.
Thank you once again for this helpful training day!
ONLINE COURSE
REGULATORY EXPERT for Medical Devices according to MDR
Very interesting topics, high level of professional competence, and very practice-oriented content.
All in all, I felt very comfortable and am taking a lot away with me.
ISO 13485 & MDR CERTIFICATION
Martin Schmid and the company en.co.tec have been advising contextflow for years in a reliable, highly competent, and well-structured manner.
The joint planning of our approval strategy led to successful ISO 13485 and MDR certification.
QUALITY MANAGEMENT SUPPORT FOR IVD
In our cooperations with en.co.tec, we have appreciated the flexible mix of available educational courses, informal round-tables about regulatory topics and the company-specific support by Martin Schmid to establish our QM-System for our IVD product. Thank you!
CONSULTING AND SEMINARS FOR START-UPS
On behalf of the MedTech Incubator and the start-ups we support, we would like to thank you for your extensive support services – from training seminars to Consulting and training opportunities.
ISO 13485:2016 & INTERNAL AUDITS & SEMINARS
en.co.tec has been a reliable partner for us for well over half a decade!
All questions and uncertainties regarding certification and the related quality management were always answered and clarified.
We look forward to continuing our collaboration.
INHOUSE-SEMINARS
The cooperation with en.co.tec is excellent and the training sessions are professionally organized. We are especially pleased that the newly acquired knowledge of our employees during the training provides added value to our daily work in production.
Susanne Fritz, HR Generalist at PAYER Austria
en.co.tec is a highly competent training partner with the ideal balance between practical application, workshops, and theory.
Wolfgang Tscherner, Quality Manager at PAYER Austria
INHOUSE SEMINARS & ONLINE COURSE: REGULATORY EXPERT IVDR
The seminars and events offered by en.co.tec have become an indispensable resource for us when it comes to quality management and medical devices.
ISO 13485
en.co.tec has been very helpful in guiding us through topics related to medical devices and has provided an excellent overview.
ONLINE COURSE
REGULATORY EXPERT for Medical Devices according to MDR
In quality management and medical device approval, much revolves around planning and preparation, but even in chaotic times, the en.co.tec team shines. with quick and straightforward solution approaches.
CONSULTING & INHOUSE SEMINARE
The collaboration with en.co.tec was very constructive and goal-oriented, both in the areas of consulting and advisory services as well as in the courses attended. For future projects, we will be happy to draw on en.co.tec’s input again.
ISO 13485:2016 & MDR CE Certification
Thank you to the team at en.co.tec for the excellent organization and delivery of the engaging presentations with Mr. Schmid and other experts in the field of medical technology.
ISO 9001 & ISO 13485
From the introduction and certification of ISO 9001, through the implementation of internal audits, up to the recent successful extension to ISO 13485 certification, we have been working with Martin Schmid from en.co.tec for years. We are glad to have such a reliable and competent contact person, who also addresses our individual ideas and requirements in a highly constructive and solution-oriented manner.
SEMINARS
As part of my preparation to become an external auditor, I decided to take several modules of the “Online Course: Regulatory Expert” from en.co.tec in order to refresh and further deepen my knowledge. This was very successfully achieved thanks to the varied lectures by Mr. Schmid, and I was pleased to be able to participate in the seminars.
INHOUSE SEMINARS
The trainers at en.co.tec always manage to make the training sessions entertaining and interesting. They impart a deep understanding of the complex regulations in the field of medical device manufacturing, especially to our new employees.
We have a competent training partner at our side with en.co.tec and would like to thank them for the many years of excellent collaboration!
ONLINE COURSE
REGULATORY EXPERT for Medical Devices according to MDR
“A person says – and is proud of it – that they immerse themselves in their duties.
But soon, not quite as cheerful, they go under in their duties.”
So that this quatrain by Eugen Roth does not come true in relation to the MDR, I have frequently continued my professional development with en.co.tec. As a participant in the 2020/21 online course “Regulatory Expert for Medical Devices,” I would like to give high praise both for the organization and for the content of the seminars.
After many years of experience, en.co.tec remains the first and best point of contact for me and my company when it comes to further training and consulting. I wish you continued success and all the best going forward!
ISO 13485 and MDR CERTIFIKATION
It is—and will probably continue to be—increasingly difficult to bring medical devices to market in Europe.
Thanks to en.co.tec and Martin Schmid, who has repeatedly guided us successfully through the jungle of standards, we were able to implement ISO 13485 and are now on the verge of launching our first MDR-certified medical device. Thank you very much
ONLINE-COURSE:
REGULATORY EXPERT for Medical Devices according to MDR/IVDR
I had a lot of fun, learned a great deal, and also got to know some very nice colleagues.
Thank you as well for the great support from your side!
ONLINE-LEHRGANG:
REGULATORY EXPERT for Medical Devices and IVD (In Vitro Diagnostics)
I have always recommended
en.co.tec
to anyone in the medical technology field looking for further training. In my experience, the courses are more tailored, easier to understand, and do not include any forced consulting pitches—unlike the “big players” in the industry.
In particular, the course for Regulatory Expert MDR/IVDR provides solid foundational knowledge. Specific questions beyond that are gladly answered directly in the seminar or afterward by email.
All in all, a pleasant gathering with plenty of learning!
ONLINE-CERTIFICATE COURSE:
Medical Software Specialist
“The course provided a comprehensive overview of all the regulatory areas before diving deeper into the specific topics. I particularly appreciated the modules on usability and cybersecurity, as the related regulations and methodologies were completely new to me, yet highly relevant to my work in medical risk management.”
ONLINE-CERTIFICATE COURSE:
Medical Software Specialist
In this training, you gain new insights and perspectives that equip you with the know-how to optimize existing approaches and processes and make them even more effective.
An excerpt from our client list:
