News

November 30, 2021 | 10-11 a.m. | Medical Devices: Overview of key differences in the approval of a medical device in the EU and USA. Where do combination products and in vitro diagnostics sort in? Register now for free!

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Renewed award of SME scholarships to two students of the master's program in biotechnology at Mannheim University of Applied Sciences. Opportunity to get to know gempex at btS ScieCon Digital Herbst on October 21.

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...and thus creates the necessary proximity, in particular to the centres of modern biotechnology. Expertise in EU-GMP, US FDA and Chinese regulations directly on site.

 

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Know How! gempex in an technical interview on the question how the effort of GMP compliant qualification can be kept as low as possible in order to ensure product quality, whilst maintaining productivity at the same time.

 

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Online seminar on 09|29|2021: gempex presents as GMP expert the areas "basics of cleaning validation, validation master plan and cleaning validation report" - highlighted by helpful practical examples.

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PMCF studies as a tool for generating clinical data. --- October 2021 --- Register now!

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Goal-oriented, efficient and good teamwork ensures a high level of trust. Gap analysis, list of measures and concept SOP, creation of QM documents, GDP trainings, qualification IT infrastructure, GDP consultancy

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New technical article from gempex:

The outlook for the medical use of THC-containing products poses new challenges for cannabis manufacturers, as the production of a medicinal product and the associated active pharmaceutical ingredient is subject to strict...

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The IMDRF (International Medical Device Regulators Forum) has defined terms related to incidents and converted them into a nomenclature. As of 2nd March 2021, the revised IMDRF codes are available.

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May 26, 2021 - THE deadline for the medical devices industry. Also for distributors and importers new requirements apply due to EU MDR and MPDG. All changes are listed clearly and understandably in the new free white paper.

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