About us
ISEMED is the answer to your needs in medical devices, IVDs, cosmetics and biocides.
Regulatory Affairs Consultancy on medical and in vitro diagnostic devices must be based on three pillars of expertise: legislative, technical and clinical.
Legislative expertise requires constant updating for all countries or geographical areas in which products are marketed; technical expertise is the result of many years' experience in the medical device field gained within manufacturing companies; clinical expertise is related to the consultant's basic training.
The choice of team members, and the constant updating on laws, standards, guidelines are the basis of the quality of the service provided by ISEMED, which for you represents the Knowledge Factory.
HISTORY
ISEMED was established in 2008 on the initiative of its founder Guido Bonapace. After 17 years as technical, quality and marketing director in companies in the medical (cardiac surgery, cardiology, pneumology, anaesthesiology) and industrial (optoelectronics) sectors, he has worked since 1998 as a consultant for medical device manufacturers and head of the medical CE marking service of a leading Italian Notified Body.
Since its inception, ISEMED has been active in the certification of medical devices in major non-EU countries and in training on all matters related to international legislative regulations.
VISION
ISEMED regards the economic activity of medical device manufacturers as a primary ethical and moral value for the individual and society, on a par with patient and healthcare worker safety. From this perspective, it is closely aligned with consideration no. (2) of the EU Regulations 2017/745 (MDR) and 2017/746 (IVDR):
The Regulation aims to ensure the proper functioning of the internal market with regard to medical devices (and in vitro diagnostics), taking as a basis a high level of health protection for patients and users, and taking into account small and medium-sized enterprises active in this sector. (…) Both objectives are pursued simultaneously and are inextricably linked, without one being secondary to the other.
MISSION
ISEMED's mission is to support the customer in addressing and resolving all aspects necessary to overcome barriers to product entry in international markets. In this way, we want to contribute to the growth of the client company, the economy of the nation and the growth of employment.
We believe in the strength of the team and the human factor, its professionalism, technical and regulatory competence.
All staff with roles of responsibility, supervision and co-ordination have many years of experience in the field at companies in the medical and industrial sectors, in order to combine the client's prerogatives and know-how with legislative requirements.
For ISEMED, the continuous updating of its staff on regulations, standards, clinical aspects and technological innovation is fundamental.
VALUES
The shared values underpinning the service provided by all employees are:
- Professionalism
- Passion for one's work
- Spirit of collaboration
- Personal honesty
- An ethical outward looking spirit (the patient, the user), and an ethical inward looking spirit (colleagues, i.e. internal customers) and customer-oriented spirit (efficiency and effectiveness)
- Attention to detail
- Humility (the individual's will to improve is the catalyst for the organisation's improvement).
WE DO NOT CLAIM TO BE THE BEST…
…BUT WE DEMAND THE BEST OF OURSELVES!
TEAM
- Nicola Berruti
CEO and Chairman of the Board of Directors - Guido Bonapace
Founder & Senior Consultant - Medical Devices Expert. - Matteo Placci
Operation Manager - Claudia Bandini
Sales & Marketing Manager - Stefano Ianni
Electronics engineer. Technical manager responsible for electromedical equipment and software - Gianluca Brusati
IT expert. Technical manager responsible for medical and process software validation - Svetlana Alexandrova
PhD in mathematics and computer science. Specialist in the Eurasian market and regulatory updates - Orsola Petrolo
Degree in Pharmaceutical Chemistry and Technology. Technical specialist in clinical evaluation and toxicology - Valentina Balbi
Bioinformatics. Specialist in human clinical trials - Valentina Cuni
Biologist and qualified lead auditor. Specialist in quality systems - Chiara Marchetti
Biotechnologist - Specialist in In Vitro Diagnostic Medical Devices, Process Validation (cleaning, sterilisation and packaging, ...) - Fiorenza Benerecetti
Biochemistry. Specialist in substance-based medical devices - Lorenzo Pasotti
Biochemistry. Specialist in substance-based medical devices - Ilaria Bedronici
Sales & Marketing - Elena Morini
Sales & Marketing - Carola Caldarelli
Nursing graduate - Clinical supervisor - Monica Gentilini
Degree in sociology - Contact person for human resources administration and management - Giuseppe Calvi
Group Marketing Manager - Mirko Magnani
Group Purchasing Manager - Gianmarco Dazza
Board member
PARTNESHIPS
- Confindustria Dispositivi Medici Servizi
- Arazy
- Intertek
- Sassuolo Hospital
- ProjectCad