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Klinische Bewertungen für medizinische Software – wenn Sicherheit kein Add-on ist!
Software, die im medizinischen Kontext eingesetzt wird, ist längst mehr als ein technisches Werkzeug. Sie stellt nicht nur medizinisch relevante Daten bereit, sondern unterstützt gezielt bei der Entscheidungsfindung, strukturiert therapeutische Abläufe und ermöglicht die frühzeitige Identifikation potenzieller Risiken. Und obwohl es qualitative Unterschiede hinsichtlich der Einsatzzwecke medizinischer Softwarelösungen gibt, gelten für diese dieselben Maßstäbe wie für klassische Medizinprodukte – zu Recht. Die Anforderungen? Herausfordernd. Die Spielräume? Müssen genutzt werden. Die Erwartungen? Klar. TentaConsult Pharma & Med GmbH unterstützt seit vielen Jahren Unternehmen bei der klinischen Bewertung ihrer Medizinprodukte – und bietet diese Leistung auch für medizinische Software an. Mit einem klaren Fokus auf das Wesentliche und einem tiefgreifenden Verständnis für…
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Clinical evaluations for medical software – when safety is not an add-on!
Software used in a medical context has long been more than just a technical tool. It not only provides medically relevant data, but also provides targeted support in decision-making, structures therapeutic processes and enables potential risks to be identified at an early stage. And although there are qualitative differences in the purposes for which medical software solutions are used, the same standards apply to them as to traditional medical devices – and rightly so. The requirements? Challenging. The room for manoeuvre? Must be utilised. The expectations? Of course. TentaConsult Pharma & Med GmbH has been supporting companies in the clinical evaluation of their medical devices for many years – and…
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Tentamus QTS Analytical Expands Testing Capabilities with Advanced GC-TOF Kit
Tentamus QTS Analytical is proud to announce the acquisition of a cutting-edge GC-TOF (Gas Chromatography Time-of-Flight) analytical kit, significantly expanding the laboratory’s scope of testing services. This investment opens new opportunities for high-sensitivity testing, particularly in the detection of: PFAS (Per- and Polyfluoroalkyl Substances) Dioxins Ethylene Oxide With superior sensitivity, resolution, and the ability to detect substances at much lower limits, the new GC-TOF system positions QTS Analytical at the forefront of advanced contaminant testing. These capabilities are essential in ensuring product safety and regulatory compliance in industries including food, feed, agriculture, and environmental monitoring. The site is currently working on the validation, with a new UKAS-accredited method expected to…
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Shelf-life surveys: A critical service by BeSafer consulting experts
BeSafer, a branch of VELTIA Labs for Life, specializes in safety consultancy services, with shelf-life surveys being one of their most sought-after offerings. As experts in safety consultancy, BeSafer’s comprehensive approach to shelf-life assessment goes beyond simple laboratory analyses, providing invaluable insights for food manufacturers and distributors. Shelf-life surveys are not just about determining expiration dates. They’re about ensuring consumer safety, maintaining quality control, meeting regulatory compliance and driving product development while considering environmental impact and cost efficiency. BeSafer’s shelf-life survey service involves a meticulous process that includes: Initial design based on multiple parameters such as organoleptic characteristics, physicochemical factors, preservatives, packaging and storage conditions. Collaboration with clients‘ key personnel…
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KEYBIO-TENTAMUS Wins „Invest in Provence“ Award and Announces Ambitious Growth Plans
It is with great pride that KEYBIO, a member of the TENTAMUS group, has been honored with the prestigious "Invest in Provence" award, recognizing its commitment and contribution to the regional economic development. During the ceremony, Jérémy LENS, representing KEYBIO on behalf of TENTAMUS, expressed their gratitude: "We would like to extend our sincere thanks to Thomas Wolf for his unwavering trust, and to Provence Promotion – the Invest in Provence agency – for this partnership, which strengthens our shared ambition of developing a dynamic and forward-thinking ecosystem." A 30-year Journey of Expertise in Microbiology KEYBIO’s story began in a small 140 m² laboratory in Aubagne, surrounded by the Garlaban…
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Wissenstransfer par excellence – TentaConsult blickt auf ein erfolgreiches 3. Medizinprodukte Symposium zurück!
Die MDR fordert – und die Branche antwortet. Nicht immer mit Applaus, aber mit Haltung, Ausdauer und dem klaren Bewusstsein, Verantwortung zu tragen. Beim 3. Medizinprodukte Symposium der Alphatopics am 12. März in Berlin wurde deutlich, was die Branche derzeit bewegt – und wo sie konkrete Antworten sucht. Die TentaConsult Pharma & Med GmbH war als aktiver Programmpartner vor Ort und blickt auf ein Symposium zurück, das durch inhaltliche Substanz, offene Diskussionen, einer Spur Humor und einen intensiven kollegialen Austausch überzeugte. Wo stehen wir in der klinischen Realität der MDR? Die Anforderungen an die klinische Bewertung und Produktsicherheit unter der MDR sind komplexer denn je. Hersteller sehen sich mit der…
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Tentamus Group Appoints Ana Mata as Chief Financial Officer for North America
We are pleased to announce the promotion of Ana Mata to the role of Chief Financial Officer of Tentamus North America. Ana first joined Tentamus in 2017 as a consultant and quickly distinguished herself as a trusted and capable leader. It wasn’t long before she was brought on as Finance Director in which she has consistently demonstrated exceptional strategic and financial insight. Ana’s educational background is equally impressive. She holds two Bachelor of Science degrees—one in E-commerce and Technology from DePaul University, and another in Accounting from Aurora University, where she also earned a minor in Business Management. She has completed a Business Analytics Certification from Cornell University and has…
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Tentamus Mandy Analytics Fuzhou Co.,Ltd. Undergoes First Aquatic Product Safety Inspection Review
From March 10–11, 2025, a three-member expert review panel, led by Pan Wei, Kang Wenbin, and Liu Haixin, conducted the first on-site evaluation of Mingcheng Tengde Testing Services (Fuzhou) Co., Ltd. (hereafter “the institution”). The review, mandated by the Fujian Provincial Department of Ocean and Fisheries, assessed the institution’s compliance with China’s Agricultural Product Quality Safety Inspection Agency Accreditation Guidelines (MOA Announcement No. 1239) and related regulations. The evaluation focused on the institution’s technical capabilities and operational protocols for aquatic product safety testing. The panel reviewed documentation, inspected chemical and microbiological laboratories, and observed practical testing procedures. Key personnel, including authorized signatories, underwent rigorous assessments. The review process incorporated interviews,…
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Does your product contain buckwheat as an allergen?
Buckwheat has become increasingly popular as a gluten-free grain alternative in recent years and is also known for its many health benefits, such as higher quality ingredients compared to conventional grains. Despite its many health benefits, it also has a high allergenic potential, ranging from mild symptoms such as itching, skin rashes, and gastrointestinal discomfort to severe, life-threatening anaphylaxis. Buckwheat allergies are particularly common in Asia, where buckwheat is a widely consumed food. A cross-allergy to buckwheat can develop, among other things, in individuals with a latex or coconut allergy. Buckwheat can cause allergic reactions not only through ingestion but also through inhalation of buckwheat flour. The prevalence of buckwheat…
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Ist Buchweizen als Allergen in Ihrem Produkt enthalten?
Buchweizen als glutenfreie Getreide-Alternative ist in den vergangenen Jahren zunehmend beliebter geworden und ist auch bekannt für seine vielfältigen gesundheitlichen Vorteile, wie z.B. hochwertigere Inhaltsstoffe als herkömmliche Getreide. Trotz seiner zahlreichen gesundheitlichen Vorteile weist er jedoch auch in hohes allergenes Potenzial auf, das von leichten Symptomen wie Juckreiz, Hautausschlag und Magen-Darm-Beschwerden bis hin zu schweren, lebensbedrohlichen Anaphylaxien reicht. Buchweizenallergien treten insbesondere in Asien häufig auf, da Buchweizen dort ein weit verbreitetes Nahrungsmittel ist. Bei einer Latex- oder Kokosnuss-Allergie kann sich u.a. eine Kreuzallergie zu Buchweizen entwickeln. Buchweizen kann nicht nur durch den Verzehr, sondern auch durch das Einatmen von Buchweizenmehl allergische Reaktionen hervorrufen. Die Prävalenz der Buchweizenallergie hat in den…
