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International Services
for Medical Devices

ISEMED is part of the Tentamus Group
Services
ISEMED provides specialized regulatory consulting for medical devices, IVDs, cosmetics, and biocides, integrating legislative, technical, and clinical expertise.
Countries
Thanks to a network of international partners, ISEMED manages regulatory submissions in over 140 countries, streamlining access to global markets.
Academy
ISEMED offers a training calendar dedicated to industry professionals, providing educational events and in-depth sessions on laws and regulations.
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Our Services

  • CE Marking

    Our goal is to guide clients through every stage of the regulatory process, supporting them with a wide range of services and ensuring a clear, pragmatic, and effective approach to the production and marketing of their products.

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    servizi marcatura ce

  • Access to Non-EU Markets

    ISEMED has developed a strong network of international partnerships to efficiently manage the preparation and submission of authorization requests to local competent authorities, facilitating market access for medical devices, IVDs, cosmetics, and biocides.

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    servizi mercati extra ce

  • Quality and Certifications

    Our team supports clients in the implementation and maintenance of quality management systems, ensuring compliance with the specific requirements of the countries where they intend to market their products.

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    service guarantee, Validation concept for business process automation, quality assurance management, certification, digital transformation. businessman touching checked icon on virtual screen.

  • Support for Pre-Clinical Activities and Clinical Trials

    We assist clients in implementing and maintaining quality management systems, ensuring full compliance with regulatory requirements in the target countries for product commercialization.

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    servizi attività preclinica e clinica

  • Regulatory Support for Medical Devices, IVDs and Cosmetics

    We offer strategic support in identifying target markets and assist clients throughout the design, manufacturing, and regulatory management phases.

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    img supporto regolatorio

  • Academy – Our Training Proposals

    The new European Regulations, Quality Standards, and Guidelines in the medical device sector affect not only manufacturers, but also resellers, distributors, and importers. For these stakeholders, ISEMED offers a schedule of training and in-depth events aimed at clarifying key topics and new legal obligations.

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ISEMED – A TENTAMUS COMPANY

ISEMED was founded in 2008 on the initiative of its founder, Engineer Guido Bonapace.
After 17 years of experience working in technical, quality, and marketing management roles within companies in the medical field (cardiac surgery, cardiology, pulmonology, anesthesiology) and in the industrial sector (optoelectronics), he began working in 1998 as a consultant for medical device manufacturers and as head of the CE marking service for medical devices at a leading Italian Notified Body.

Since its inception, ISEMED has expanded into medical device certification in major non-EU countries and has offered training on all topics related to international regulatory legislation.

In 2022, ISEMED joined the Tentamus Group in Italy with the goal of providing companies with highly qualified technical and regulatory support for international market development of Medical Devices, IVDs, cosmetics, and biocides.

 

ABOUT TENTAMUS

Tentamus GmbH is a global network of specialized companies and laboratories that has been operating since 2011 to ensure the quality and safety of food, cosmetics, pharmaceuticals, and medical products. Today, the Group includes over 90 locations worldwide (Europe, the United Kingdom, Israel, China, Japan, India, and the United States), with more than 4,000 highly qualified employees working across more than 3 million square meters of laboratory and office space.

 

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