From now you can see how effective and reliable Thema is thanks also to the certification ISO 13485:2016 and ISO 9001:2015, recently got.

More and more, regulatory affairs process is a strategic element, critical at the same time, for all medical device companies and THEMA wants to give a concrete sign of professionalism and quality management to the advantage of the its own Customers.
After an intense work, THEMA’s journey towards the certification of the quality management system has finally come to an end (and started, at the same time). The recent inspection of the Certified Body IMQ, in fact, has assessed the compliance of THEMA organization to the new standards.

Proudly, we can say that nowadays we are the very first organization in our field to be certified with the last version of the two standards.

Which benefits for you? So many! Here are some:

  • More effectivenessin THEMA services – the controlled management of our processes will allow us to support you more quickly and effectively.
  • Specialized Partner – our team will be able to manage the most critical processes and the most difficult regulatory affairs projects, giving you a professional support to define your marketing strategy.
  • Qualification as critical supplier – The global regulations recommend (and sometimes oblige) to consider the regulatory affairs partner as a critical supplier. The compliance to ISO 13485:2016 certification will facilitate you in front of the Regulatory Authorities to demonstrate THEMA qualification to operate in the medical field.

“We are so pleased to have reached this ambitious goal. – commented Marisa Testa, CEO – Thanks to all THEMA’s team! This is another step towards one of the most important goal: becoming a real landmark for our Customers.”