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More time to be ready for IVDR?

About 90 % of all in vitro diagnostic (IVD) manufacturer cannot benefit from transition period laid down in Article 110 of Regulation (EU) 2017/746 (IVDR) and must be ready for IVDR in May 2022. The new Regulation will replace the current Directive 98/79/EC on in vitro diagnostic medical devices from 26 May 2022. The main
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Drug-Device-Combinations acc. to article 117 MDR

With the entry into force of the Medical Devices Regulation (EU) 2017/745 (MDR) at the end of May 2021, there have not only been many new and mostly more complex requirements for manufacturers of medical devices. Article 117 MDR also amends Annex I of the Medicinal Products Directive 2001/83/EC on so-called drug-device combinations to the
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Medicinal product or medical device? – Webinar

 March 30, 2021, 3 pm cet     In which category does my product belong? This is often a non-trivial question.   In theory, medicinal products and medical devices can be very appropriately distinguished in terms of their modes of action and thus their medical purposes: while medicinal products exert their effect in a pharmacological,
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Brexit Pharma

Brexit // Where do we go from here?

A cautious agreement has been reached for the future relationship between the European Union and Great Britain. Here are some facts about the given Brexit scenario regarding the pharmaceutical and pharmacy sector: The agreement contains specific provisions for both the pharmaceutical and pharmacy sectors, which are not as comprehensive as hoped: There will be separate
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Biocompatibility: No plan – no report!

  Among all the hurdles that the legislator has set up before medical devices can enter the market, the proof of biocompatibility poses particular challenges. Specialized service laboratories have an impressive number of corresponding tests in their repertoire: But which of these does your medical device really need?   In principle, the answer to this
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VELTIA Labs for Life Cyprus has updated its Scope of Accreditation!

“Your life’s quality, our top priority” – VELTIA Cyprus is committed to VELTIA LABS FOR LIFE’s motto and has set a clear target for 2021. The goal was to upgrade its nutritional lab and provide its clients the services of one “stop-care lab”. “After a successful 4-day-audit conducted by CYS-CYSAB (Cyprus Accreditation Body) we are
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Foundation of Tentamus Pharma & Med Deutschland GmbH

Formation of a new company out of BLS-Analytik GmbH, TentaMedix GmbH and DSIpharm Oldenburg The Tentamus Group pleased to inform you that BLS Analytik GmbH, TentaMedix GmbH and DSIpharm Oldenburg have merged as one company with immediate effect as Tentamus Pharma & Med Deutschland GmbH. The company’s headquarters are located in Bad Kissingen, Columbiastraße 14
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Laboratorio Control extends its ENAC scope in Feed, Food and Food Additives

Committed to the continuous improvement of its analytical services, Laboratorio Control extends its ENAC (National Accreditation Body) accreditation in the Food and Animal Nutrition sectors.   The Molecular Biology Department of the laboratory has successfully passed the ENAC audit which focused on the evaluation of the analytical method for the detection of Salmonella spp. and
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Laboratorio Tello at EXPOLIVA 2021

Once again, the team of Laboratorio Tello did not miss one of the main events of the olive oil sector at international level: EXPOLIVA 2021, International Fair of Olive Oil and Related Industries, which ended 25th of September at the Provincial Exhibition and Conference Centre (IFEJA) in Jaén. Despite the exceptional situation due to the
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BAV Institute extends its scope of accreditation

The BAV Institute from Offenburg is pleased to announce that the recently conducted eight-day audit within the scope of accreditation according to DIN EN ISO/IEC 17025 was passed successfully again. A special highlight is that also the culture media production and testing according to DIN EN ISO 11133 has been successfully assessed and will be
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Analytical Food Laboratories offers first ever PCR Cyclospora testing platform

Grand Prairie, Texas: Analytical Food Laboratories motto is keeping people safe since 1992 using integrated solutions, technical expertise, local approach, global results, and quick response times. AFL is a true one-stop full-service lab that provides tailored interpretation and consultative approach to deliver measurable results. All departments are housed in one location, and all services are
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Ethylene oxide is detected in more and more food products!

In the recent past, numerous products containing sesame seeds, locust bean gum, xanthan gum and thickeners were recalled from the market because the maximum residue levels for ethylene oxide were exceeded. In the EU, food business operators are responsible for having their products tested for residues as part of their own inspections. According to Regulation
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Old woman - brain - puzzle - alzheimer

Aducanumab – first new treatment approved for Alzheimer’s since 2003

Alzheimer disease: Alzheimer’s is responsible for 60% of the world’s estimated 50 million dementias. The heterogeneity of the disease makes Alzheimer’s diagnosis and counting the total number of affected people difficult. Every fifth patient has an atypical Alzheimer’s disease, which is often not recognized This progressive neurodegenerative disease starts with microscopic changes in the brain
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Preservation Challenge Tests Cosmetics Tentamus

Preservation Challenge Tests for Cosmetics according to ISO 11930

How can we ensure that a cosmetic product remains stable against microbiological influences?   Preservation challenge tests represent a fundamental building block for evaluating the microbiological safety of cosmetic products. The test is intended to confirm that the cosmetic product prevents germ multiplication when used as intended and is therefore microbiologically stable. The ISO 11930
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