NEWS
March 03, 2022
Press release: IVDR Survey Results: Majority of Companies Still in the Middle of Preparations and “Timelines” Considered Greatest Challenge
Software company Climedo and contract research institute TRIGA-S Scientific Solutions have completed their joint survey on the IVDR (Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices). The results show that the IVDR requirements are already clear to most companies, but the majority are still in the midst of preparations. Few have started EUDAMED registration and only half of the respondents have a Notified Body.
- The full survey results can be downloaded here.
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March 03, 2022
Press release: Climedo and TRIGA-S Launch Survey on the Status of IVDR Implementation
Software company Climedo and contract research institute TRIGA-S Scientific Solutions have published a survey on the European In Vitro Diagnostics Regulation (EU-IVDR 2017/746). The survey is aimed at diagnostics manufacturers of all sizes and product classes. The purpose of the survey is to determine the status of implementation of the IVDR requirements and any potential need for further information.
November 24, 2021
Christmas in a shoebox 2021 – make a big difference with small things!
Many of our employees and the management of TRIGA-S Scientific Solutions support the Christmas in a shoebox campaign every year to give children a little joy and hope for Christmas. Our longtime employee Monika Sonner is particularly committed to the local organization of the collection, repackaging and further transport to the collection points of what is perhaps the world’s largest gift campaign.
July 01, 2021
We congratulate our first trainee Luisa Neumeier on her successful graduation!
The specialist for in-vitro diagnostics services, TRIGA-S Scientific Solutions, congratulates Luisa Neumeier on successfully completing her professional training as Kauffrau for Office Management. After almost three years of professional training, Ms. Neumeier is now holding her diploma from Beruflichen Schulzentrum Schongau in her hands.
Sabine Müller, Head of Training: “I was delighted to be able to accompany Luisa’s great development. She has proven to be a very committed trainee who was able to quickly take on responsibility. Thanks to the support and collaboration in several departments, she was also able to gain a good overview of our company. ”
Christine Hutter, Head of Finances and Human Resources: “We are very proud that Luisa was able to complete her training with such great success as our first apprentice and we are very pleased to welcome her as a permanent member of our team. We hope for a long-lasting and very good cooperation. “
June 24, 2021
MedTech Connect – Free Webseminar & Exchange (German language): “IVDR as Opportunity”
Lectures and exchanges as part of the digital event #MedTechConnect on June 24th at 3.00 PM – 5.30 PM – with Dr. Michael Reil from TRIGA-S Scientific Solutions – don’t miss it!
April 16, 2021
Free Webinar (German language): “IVDR 2017/746: The new way to the market for in-vitro diagnostics”
Attention all IVD developers/manufacturers and those interested! BioM Biotech Cluster Development GmbH invites you to the free webinar “IVDR 2017/746: The new way to the market for in-vitro diagnostics” on Friday, April 16, 2021 at 10 am-1pm. Five experts will explain how the path to IVDR conformity looks like, including Dr. Jens Hain from TRIGA-S Scientific Solutions in his lecture “Analytical and clinical performance evaluations according to IVDR”. A round of questions and discussions with the speakers will round off the seminar.
December 22, 2020
Dr. Andreas Franke new COO at TRIGA-S Scientific Solutions
Effective 1st January 2021, Dr. Andreas Franke will take overall responsibility of TRIGA-S operations. In his new role as Chief Operating Officer (COO), he will drive the company’s growth course and support the management with Sabine Radiske (CEO) and Christine Hutter (CFO). Most recently, Dr. Franke successfully headed the project management of TRIGA-S.
Press release in German language:
December 11, 2020
BAYERNS BEST 50: TRIGA-S awarded in 2020!
With the BAYERNS BEST 50 award, the Bavarian Ministry for Economic Affairs, Regional Development and Energy, honors the 50 fastest growing medium-sized companies from around 8000 applicants that have increased the number of of employees and turnover above average in recent years. Our founder and CEO Sabine Radiske expresses her gratitude with a video message, also on behalf of all employees, for the BAYERNS BEST 50 award in 2020:
December 10, 2020
New Yearbook of BIO Deutschland 2020/2021 published today (in German language) – with article by TRIGA-S!
Das Today, the new Yearbook of BIO Deutschland e. V. was published containing many interesting articles on the status of biotechnology in Germany. TRIGA-S Scientific Solutions has also contributed with an article in the yearbook, authored by Dr. Michael Reil and Dr. Jens Hain: “IVDR-Konformität bis 2022: Wir bereiten Sie vor!” (IVDR conformity until 2022: We help you prepare!).
Here you can obtain the yearbook in German language:
September 23 to 24, 2020
N-Tec Talks parallel to the W3+ Fair Rhine Valley: Lecture by Dr. Jens Hain from TRIGA-S
We are happy to announce that we will take part in the upcoming W3+ Fair Rhine Valley in Dornbirn, Austria. Dr. Jens Hain from TRIGA-S will give a lecture on regulatory requirements and analytical performance assessments for COVID-19 diagnostics.
June 29, 2020
We are now ISO 13485 certified!
Following a successful certification audit, today we are very glad to announce that we, in addition to our long established DIN EN ISO 9001:2015, have now also implemented the DIN EN ISO 13485:2016 Quality Management System for the scope Tailor-made project solutions as part of technical and clinical performance evaluation studies for In-Vitro-Diagnostics. This important milestone has been achieved through hard work, many helping hands and minds of the great team at TRIGA-S – a special Thank You goes to our Head of Quality Management, Dr. Marion Horsch, and our Head of Quality Assurance, Sebastian Behrend (picture). With a deep commitment to quality in everything we do, we strive for the highest possible level of documentation and traceability in the services we deliver.
June 18, 2020
Free Webinar with TRIGA-S: “Focus on IVDR – Preparation and Critical Questions” (German language)
Dr Jens Hain from TRIGA-S will be one of the presenters at the upcoming webinar on 18 June 2020, 10:00 AM – 12.30 PM CEST, hosted by Kalms Consulting and Taylor Wessing Germany. The focus of the session will be the practical implementation of new IVDR requirements for manufacturers. The Webinar will be conducted in German language. Register today at: registration@kalmsconsulting.com.
May 20, 2020
“Performance Evaluation of COVID-19 diagnostics”, new article by Dr. Lisa Mutschelknaus, Study Manager at TRIGA-S│transkript 2.2020:
In her article, Lisa Mutschelknaus gives an overview of what is currently required for COVID-19 diagnostics in relation to performance evaluations.
Link to the article (German language):
transkript_02_2020_leistungsbewertung-von-covid-19-diagnostika_lm
April 8, 2020
TRIGA-S supports COVID-19 diagnostics manufacturers with analytical and clinical studies for fast-track regulatory approval
In response to the COVID-19 crisis, we are experiencing an impressive effort by diagnostics manufacturers to develop tests for different clinical settings and purposes. Under the current circumstances, regulatory authorities, e.g. FDA and BfArM, grant emergency authorization, requiring clinical evidence for test specifications, such as sensitivity and specificity. We at TRIGA-S are well prepared to support IVD manufacturers with the necessary analytical and clinical study services in order to achieve quick market entrance for the assays. Our services also include the procurement and management of clinical samples (e.g. nasopharyngeal swabs , serum and plasma) as well as full material and study logistics worldwide.
March 24, 2020
TRIGA-S participates in COVID-19 initiatives
During the COVID-19 pandemic, several R&D exchange platforms are organized, e.g. by Bio-M and Gesundheitsindustrie BW, where also TRIGA-S supports as service provider:
December 16, 2019
BIO DEUTSCHLAND –
Meeting of the working group Diagnostics
Presentation by Dr. Jens Hain, TRIGA-S:
“Clinical and analytical studies according to the new EU IVD Regulation – efficient and cost-effective execution with the support of an IVD experienced CRO”
November 29, 2019
BVMA symposium in Munich
November 27 to 28, 2019
Diagnostics-4-Future Conference in Konstanz
September 30 to October 1, 2019
MMM Workshop 2019 – spot your future
Vienna
Presentation by Dr. Jens Hain, TRIGA-S:
The enhanced requirements in the new European In Vitro Diagnostic Regulation (IVDR) for clinical performance evaluations with IVD in order to obtain the CE certification
September 18 to 19, 2019
W3+FAIR Rheintal 2019
Dornbirn/Austria
Keynote presentation by Dr. Jens Hain, TRIGA-S:
“The new rules for clinical performance evaluation in the field of in vitro diagnostics and medical devices and their importance for manufacturers”
July 11, 2019
KIKS Workshop in Stuttgart
Keynote presentation by Dr. Jens Hain, TRIGA-S:
“Clinical performance evaluation studies of medical devices according to the new MDR”
May 21 to 23, 2019
MedtecLIVE, Nuremberg
We exhibit, visit us at our booth 9-304 in hall 9.
We look forward to seeing you!
May 8, 2019
BioLAGO Academy:
Successful tackling and mastering of the IVD and MD regulation
Presentation by Dr. Jens Hain, TRIGA-S
April 10, 2019
BIOVALLEY-MEETING POINT LÖRRACH
Topic of the year 2019: Multi-resistance –
a challenge of medicine and biotechnology
Presentation by Dr. Jens Hain, TRIGA-S:
Diagnostics for multi-resistant pathogens: analytical and clinical performance studies regarding the new IVDR
March 11 – 13, 2019
4th POINT-OF-CARE TESTING SYMPOSIUM IN MUNICH
Point-of-Care Testing at the Interface of Emerging Technologies and New Clinical Applications.
Presentation by Dr. Jens Hain from TRIGA-S:
“Clinical Trials according to the new IVDR to get POCT devices on the market – Some carrots and many sticks.”
