Compliance Requirements for Medical Device Software and Software as a Medical Device (SaMD) in the US and EU Compliance Requirements for Medical Device Software and Software as a Medical Device (SaMD) in the US and EU In this post, we will discuss specific compliance requirements in the US and Europe for medical device software [...]
Oriel STAT is a New Jersey-based consulting firm that provides MDSAP auditing, QMS implementation, private team training, and related services for the medical sector.