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Access to international markets: new business unit of TÜV NORD Argentina

Bradley Chen (left) and Amadeo Berdou explain the MDSAP scheme to the audience.

As part of the first Medical Devices Single Audit Programme (MDSAP) on the Argentinian market, Bradley Chen, head of the Medical Devices Division of TÜV USA, joined forces with Amadeo Berdou, Managing Director of TÜV NORD Argentina, in the presentation of this new scheme.

The conference took place in the Instituto Tecnológico de Buenos Aires, recognised as one of the foremost universities in Argentina for technical expertise and a leading institute for bioengineering studies in Argentina.

Bradley Chen (TÜV USA, from left), Amadeo Berdou (TÜV NORD Argentina), Nestor Rava (Lexel)  and Matias Madorno, Managing Director of MBMed after the event.

With the participation of around 85 professionals from the market, it was a great success and demonstrated the key importance of the certification issue on the Medical Devices business agenda.

To be able to guarantee the safety and quality of medical devices for both users and patients is essential for both regulatory and ethical reasons when it comes to the marketing of any related product.

The attendees – students and graduate bioengineers from ITBA, local regulation authorities, manufacturers, service companies and consultants – showed a great deal of interest in the topics presented and interacted freely with the speakers. The agenda was:

  • Presentation of the Event – ITBA – Matias Madorno
  • Access to International Markets – TÜV NORD Argentina – Amadeo Berdou
  • Certification Experience – Lexel – Nestor Rava
  • Introduction to the MDSAP Programme – TÜV NORD USA – Bradley Chen

 

In Argentina, services related to medical devices have as a rule previously been offered by external companies with no resources in the country. In response to this lack of local services, TÜV NORD Argentina nominated an officer, Ramiro Casas, to offer these services with local representation while also drawing on the support of TÜV USA. The audits performed locally with foreign auditors are being used to train local resources to enhance their competitiveness and reinforce their presence in the future.

The services offered within this new business unit are:

  • ISO 13485 certification
  • MDSAP cerfitication
  • CE marking (product certification)