28 November 2026 is the deadline for registering in EUDAMED medical devices and in vitro diagnostic medical devices that were already placed on the market before 28 May 2026 and for which further units continue to be placed on the market from that date, subject to the conditions and exceptions set out in the applicable […]
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NOVA Biologicals, a Tentamus company, is expanding its GMP pharmaceutical microbiology capabilities with the addition of USP <72> Rapid Sterility Testing. USP <72>, Respiration-Based Microbiological Methods for the Detection of Contamination in Short-Life Products, provides a compendial approach for validated rapid sterility testing when appropriate for the product and testing program. The new capability provides […]
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As the cosmetics industry continues to move towards more sustainable products and packaging, manufacturers are navigating an increasingly complex balance between environmental ambitions, product safety, quality and performance. To explore some of these challenges, Tentamus will bring together three experts from across its global network for a webinar on 29 October 2026, covering microbiological safety, […]
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Das Verfahren liefert zuverlässige Ergebnisse innerhalb von maximal 48 Stunden – auch dort, wo klassische Kultivierungsverfahren an ihre Grenzen stoßen. Probiotika gewinnen als Bestandteil der Ernährung vieler Menschen zunehmend an Bedeutung. Mit den steigenden Anforderungen an Qualität, Produktsicherheit und den Nachweis der enthaltenen Mikroorganismen wächst auch der Bedarf an zuverlässigen mikrobiologischen Untersuchungsmethoden. Das BAV Institut […]
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QTS Analytical – A Tentamus Company is pleased to announce its designation as an Official Laboratory for Organic Controls by the Department for Environment, Food & Rural Affairs (DEFRA) under Article 37 of Assimilated Regulation (EU) 2017/625, the Official Controls Regulation. The designation enables Tentamus QTS Analytical to carry out pesticide residue testing in support […]
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As part of our commitment to digital transformation and operational excellence, Axens is partnering with Picomto, a French software company specializing in digital work instructions and connected worker solutions. By leveraging Picomto’s expertise, Axens is accelerating the digitalization and automation of its operations, replacing remaining paper-based procedures with interactive, user-friendly digital work instructions. The solution […]
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Tentamus Agriparadigma, an ISO/IEC 17025-accredited laboratory, has integrated a robotic system into its analytical workflow for the purification of food samples intended for pesticide residue testing. This innovation is particularly significant given the scale of the laboratory’s operations: it processes over 40,000 samples annually in accordance with EN 15662, the European reference standard for multi-residue […]
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Regulatory requirements must be taken into account well before market entry. Decisions are made as early as the development, quality management and scientific evaluation stages that shape subsequent evidence, product classifications and regulatory requirements. Those who only consider these interrelationships at the end of a process risk inconsistencies between documentation, the product concept and regulatory […]
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Regulatorische Anforderungen müssen lange vor dem Markteintritt berücksichtigt werden. Bereits in Entwicklung, Qualitätsmanagement und wissenschaftlicher Bewertung werden Entscheidungen getroffen, die spätere Nachweise, Produkteinstufungen und regulatorische Anforderungen prägen. Wer diese Zusammenhänge erst am Ende eines Prozesses betrachtet, riskiert Widersprüche zwischen Dokumentation, Produktkonzept und behördlicher Erwartung. Die TentaConsult Pharma & Med GmbH begleitet Unternehmen mit Arzneimitteln, Medizinprodukten, […]
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Columbia Laboratories is proud to announce the successful development and launch of new Paraquat and Diquat analysis services, expanding our Polar Pesticide testing capabilities. As global regulatory scrutiny intensifies, these nonselective herbicides, which are widely used in agricultural and industrial settings, require precise and reliable monitoring. Because these compounds can migrate into agricultural runoff, groundwater, […]
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