ISEMED, based in Imola (BO), Italy, provides consulting services for medical devices, in vitro diagnostic medical devices, pharmaceuticals, and cosmetics on the European and international market.
ISEMED experienced and trusted partner to its customers, supporting its customers’ technical, economic, commercial, and regulatory development in the main economic regions, worldwide.
“Our goal is to provide Italian Companies the greatest possible technical and regulatory competence and an effective support for the development of the international market of medical devices, IVD, cosmetics, biocidal products. We help Companies to establish regulatory strategies in order to avoid the pitfalls imposed by local laws that slow down the production and commercial process.
Our competence is proven by numerous training courses, which we provide on behalf of the main Italian Notified Bodies, as well as by Master’s Degree II course in Clinical Engineering for the University of Bologna, which I personally carry out”, explains Eng. Guido Bonapace of ISEMED.
The Country Manager of Tentamus Italia, Nicola Berruti adds: “With great enthusiasm, we are entering a sector, the Medical Device one, which is characterized by a strong dynamic and a very high level of innovation. The entry of ISEMED within the Tentamus Group therefore represents a fundamental step for the enhancement of our service offering and the growth of Tentamus in Italy but also globally: our aim is to offer the life-science industry an increasingly complete and rooted service across various sectors.”
ISEMED is the only consulting firm in the medical sector in Italy accredited by the Economic Development Ministry (MISE) as Temporary Export Manager (cod. TEM_00000142).
ABOUT ISEMED SRL
ISEMED Srl, is a consulting company that aims to assist companies to market medical devices, IVDs, cosmetics, biocides and PMCs.
More specifically, the company focus is on international registrations and approvals, quality systems, territorial representation, clinical evaluation, product and process software validation, quality management systems, process reengineering, project design support and training for companies in the sector. Please find further information at https://www.isemed.eu
Tentamus Group GmbH was founded in 2011. Tentamus is a global product and safety group with a core presence in Europe, UK, Israel, China, Japan, India and the USA. Accredited and licensed Tentamus Group tests, audits and consults on all products involving the human body (food & feed, pharmaceuticals & medical, agrosciences, cosmetics, agriculture & environment and nutraceutical & supplements). Tentamus Group is represented in over 90 locations worldwide. More than 4,000 highly-trained staff members work in over 3 million square feet of laboratory and office spaces. For further information please visit www.tentamus.com.
Tentamus Group
An der Industriebahn 5
13088 Berlin, Germany
www.tentamus.com
Tentamus Group GmbH
An der Industriebahn 26
13088 Berlin
Telefon: +49 (30) 206038-230
Telefax: +49 (30) 206038-190
http://www.tentamus.com
CEO
E-Mail: nicola.berruti@tentamus.com
General Manager ISEMED Srl
Telefon: +39 335 537 86 86
E-Mail: gbonapace@isemed.eu
