Current developments at our company
01.03.2019 - Article about us appeared in the DeviceMed!
Article about us appeared in the DeviceMed!
There is a new article about our work in particle measurement on medical devices. The particle measurement is becoming more and more the focus of the Notified Bodies, but evaluating the results and setting the acceptance criteria is not easy.
We give our customers the necessary advice and assistance.
21.02.2019 - Joining Expert Table CleanMed
Joining and our 1st meeting at Expert Table CleanMed!
We joined the Expert Table CleanMed. The task of the working group is to define, establish and continuously update the guideline for cleanliness for medical devices. Core areas and groups that have been formed are: further development of the previous guideline "SME Guidelines for Standardized Cleaning of Surgical Instruments" from 2017, as well as the standardization of particle measurement and quantification according to suitable standards. We attended the meeting of the Expert Tables on 19th Feb 2019 and contributed our expertise in particle quantification. If you would like information about the current state of knowledge regarding particle measurement or are interested in the test, please contact us. Our contact persons are there for you!
11.01.2019 - We are at the IMRP19 in Strasbourg!
We will be attending the IMRP19 in Strasbourg from 1 - 5 April 2019!
We were just informed, that the company Framatome GmbH will held a lecture at the IMRP on the upcoming modernization of our sterilization plant! The following link leads you to the abstract of the lecture https://cm.imrp-iia.com/mobis/lecture/110
The IMRP19 (International Meeting on radiation processing) will be taking place in Strasbourg from 01 - 05 April 2019. International companies will meet in the congress and exhibition centre to discuss the latest developments in science and business on the subject of radiation processes.
We will be represented on site with our booth (number 5) and look forward to your visit!
Click on the picture to download further information about this congress as PDF.
21.12.2018 - We are at the T4M in Stuttgart!
17.09.2018 - BBF successfully accredited again!
Extended accreditation scope for medical devices and pharmaceuticals
As our testing laboratory has been accredited according to ISO 17025 for the testing of medical devices since 2013, we have now successfully completed the renewed audit with a significantly extended scope of accreditation. It should be stressed in particular that the scope now covers not only medical devices but also pharmaceuticals and active substances.
The accreditation covers an extensive spectrum of tests in the fields of biological, microbiological-hygienic and physical testing of medical devices and their packaging as well as in the fields of pharmaceutical and active substance microbiology, pharmaceutical technology and environmental monitoring.
New additions to the accredited catalogue of services include testing for bacterial endotoxins using the recombinant Factor C test (EndoZyme, EndoLISA) and testing for particle contamination by light blockade of medical devices and pharmaceuticals. (Contact person: Dr Christopher Rösch, Tel.: 07151 – 94570-21)
So that we may be able to offer you a demand-oriented and comprehensive range of qualified testing services for medical devices and pharmaceuticals in the future, we will continue to strive to constantly expand our range of services.