NEWS
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.”
