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Systems and procedure packs

How to pack medical packages Both the MDD 92/43/EEC and the MDR 2017/745 allow packages of different products that are combined in a meaningful context for a specific intended use to be placed on the market. According to the MDD, these must be CE-marked products. The MDR also allows non-CE marked devices if their presence
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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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Tentamus Group welcomes its first laboratory in Portugal!

Globalab, a laboratory specialized in microbiological analysis for the Environmental and Food industry, becomes the first Tentamus laboratory in Portugal. Based in Marinha Grande (Portugal), Globalab offers a wide range of microbiological analytical services focused on the agri-food and environmental sector. Globalab opened its doors in 2004 and has since become a reference laboratory in the
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Tentamus - Partnership with Horn & Company

Tentamus Group and Horn & Company enter into partnership

Combined expertise for retail & life science industry   The Tentamus Group, a global network of highly specialized laboratories in the life science sector, is pleased to announce the conclusion of a long-term cooperation with the top management consultancy Horn & Company. Both companies are already independently recognized as “hidden champions” in their respective industries. 
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Detection of eggs as an allergen

In the EU, 14 substances are defined that can cause allergies or intolerances when consumed. These substances are listed in Annex II of Regulation (EU) No. 1169/2011 and includes, among others, chicken eggs. Substances that may cause allergies or intolerances must be highlighted in the list of ingredients according to Article 21 of the Food
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SMS Expansion – Cosmetics Testing Services

Southern Microbiological Services (SMS Ltd.) has been offering UKAS accredited microbiological testing services to the food and drinks industries since it was established in 1987. Our laboratory is also RSA approved. Located near Wellington, Somerset, in the UK, SMS Labs is excited to be able to extend our offering to include cosmetic testing.   Sally
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A new laboratory is joining the Tentamus Group in Italy!

The Tentamus Group is proud to welcome C.A.I.M. Analysis Laboratory to its international network of laboratories and service providers.   Based in Follonica (Province of Grosseto, Italy), C.A.I.M. Laboratory offers chemical and microbiological analysis and consultation services, providing valuable support to companies operating in the agri-food, oenological and environmental sector.   C.A.I.M. is among the
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Analyst GMP Certification Extension

The Israeli MoH notified Analyst Research Laboratories that it has successfully passed its latest audit and has been rewarded with an extension of its GMP certification. The Israeli Institute for Standardization and Control of Pharmaceuticals operating under the Israeli MoH, is recognized by the European Commission under the Agreement on Conformity Assessment and Acceptance of
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Tentamus Pharma Group at CPhI worldwide 2021

The Tentamus Pharma Group bundles all competences in the field of drug and medical device testing and is made up of class leading independent laboratories, providing high quality service and support to our clients worldwide. Our client base ranges from small start-up companies to multi-national corporations, encompassing a comprehensive and diverse portfolio of services to
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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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