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TÜV Rheinland Italia: the medical sector as a sign of the growth of the important international certification body

06.03.2021Bologna - Italy

The medical team of  TÜV Rheinland Italia

New milestones in the history of TÜV Rheinland. Since 2014, the date of the opening of the Bologna branch, a growth trend has been developed. This trend, in just over five years, has steadily established itself in the leadership of the Italian medical panorama, also facilitating new important structural developments.

The medical team of TÜV Rheinland Italia, in the context of the principles followed, has decided to put people first by emphasizing skills and their value; the team has been able to undertake a path of trust with manufacturers built on the basis of seriousness and professionalism.

For manufacturers who need experience and competence, here more than in other sectors, the need to resort to a Certification Body that guarantees reliability is an obligation that leads the medical market to turn only to those who truly transmit certainties and safety.

The human factor, competence and professionalism are the center of the development project of a winning reality that is already oriented towards the future, for the medical department of TÜV Rheinland Italia. It is on this basis that the medical team, absolutely aligned with these values, has been consolidated. These characteristics have been able to strongly distinguish the service provided for reactivity and results achieved.

TÜV Rheinland Italia employs experts with many years of experience in the medical world where the expertise has been able to combine the experience born from the knowledge of the production realities of the sector with the verification and certification processes. The service is completed by experienced doctors in the various specializations to support clinical examinations on products.

"It is a team that has achieved important goals and which will continue to grow and reach new ones, I am sure" says Massimiliano Testi, Head of the Medical Devices sector of TÜV Rheinland Italia, who underlines how " the experience and professionalism of this team, recognized and appreciated by the market, has allowed us to be among the market leaders in Italy in a short time and also represent a source of pride for the German parent company. We have worked with passion and care and we will continue to do so in compliance with the rules and aware of the credibility we have gained."

In line with the evolutions that have marked the year 2020 of TÜV Rheinland Italy for the courageous choices made, the new headquarters in Bologna has also been made official, moved to a completely new and enlarged location compared to the previous one. The new headquarters in Bologna represents part of the evolution and growth of TÜV Rheinland Italia in the services related to the Certification of all Management Systems and product verifications. In fact, it is connected to the new and important expansion of the laboratories at the main headquarters in Pogliano Milanese. This expansion will make it possible to increase the capacity and timing of test execution, in order to further increase service performance. "Not only with a view to testing", continues Paolo Caglio, CEO of TÜV Rheinland Italia, "we have already planned activities for the near future, aiming for new accreditations, test extensions and anything else that will allow us, already in the next few months, to be able to respond to new needs of the biomedical market ", first of all the awaited notification for the new 2017/745 Regulation. In fact, since July of last year, the verification of the European Commission was supported with excellent results, in particular thanks to the investments made in terms of hiring staff and increasing the technical structure to continue to guarantee the professionalism of the services provided in the medical field.

In this context, the services for the medical sector of TÜV Rheinland Italia were able to meet the new mandates, thus becoming even more professional, serious and authoritative.

Those who decided to get certified with TÜV Rheinland Italia, in the phases of strong instability recorded since the beginning of 2018 in which there was the dismissal of many Notified Bodies, were able to benefit from concrete, qualified and increasingly referenced services from the device market doctors. This demonstrates the importance of maintaining consistency with your investment project and the will to continue growing at a European level to support all the technical-legal evolutions that are taking place.

For medical device manufacturers, choosing TÜV Rheinland means ensuring the reliability required by the market for its future challenges.

Services in the medical field

  • Issue of ISO 13485 and ISO 9001 Certifications for Quality Management Systems.
  • MDSAP Audit.
  • CE1936 marking with authorization from the Italian Ministry of Health.
  • Testing and certification activities with internationally recognized reports (eg INMETRO, cTÜVus).
  • Issue of accredited test reports (ACCREDIA / ILAC scheme).
  • CB certifications (IEC scheme).
  • Integrated Solutions.
  • Specialized courses.

TÜV Rheinland Italia combines the visibility of an internationally recognized brand with high professional profile skills, to ensure reliable and authoritative assessments, able to meet the demands of international markets.

Another distinctive element in the technological field are our specialized and accredited laboratories for the medical device sector, which carry out globally recognized tests.