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General conditions the extension of the transition period Compliance with Directive 90/385/EEC or Directive 93/42/EEC. No significant changes in terms of [...]

After the third extension of MDR (EU) 2017/745, formalised by Regulation 2023/607, it is increasingly difficult for manufacturers of legacy devices [...]

Due to the absence of a mutual recognition agreement with Europe, there are several regulatory requirements for the marketing of Medical Devices [...]

Due to the changes introduced by the European regulation, it is necessary to have a good understanding of the role and [...]

This Strategic Partnership will enable EMMA International and Thema to Increase Their Geographical Offerings for the Medical Device Industry Bingham Farms, [...]

Since MDR came into force, a lot has changed in the European context: in fact, MDR has sought to involve functions [...]

The topic of usability was only of interest to the world of software and electronics, but it has rapidly spread to [...]

It may be difficult for a medical device company to choose the right partner and achieve its marketing goals, especially if [...]

The Person Responsible for Regulatory Compliance (PRRC) is one of the most critical elements of MDR (EU) 2017/745 as the responsibilities [...]

It is with great pride and satisfaction that we announce that THEMA is joining to the international Organization RAPS - Regulatory [...]