Oriel, together with NELA’s regulatory team, will be in charge of defining the regulatory strategy for both the US and EU markets, including necessary meetings with either the FDA or Notified Body as part of the approval/certification process.

Oriel STAT A MATRIX is a global consultancy and training firm focused on medical device regulatory compliance, quality management, auditing, and training for US and international regulations. Oriel’s consultants have an average of 25+ years of international and domestic industry experience. All have active, in-depth knowledge of current and proposed regulations; they use this expertise to provide practical interpretations of both US and European requirements.