InterSystems is a software and technology company renowned for developing high-quality solutions in the fields of database management and healthcare information systems.
We provided legal assistance to Intersystems regarding the regulatory framework for Software as a Medical Device (SaMD) within the context of an agreement with a well-known and prestigious clinic. Our role encompassed a comprehensive review of the agreement and a meticulous analysis of SaMD regulations. The interpretation and application of these specific regulations are notably intricate, owing to the expansive definition of a medical device and its specific implications within the context of Peru.
Estudio Olaechea has provided a specialized assessment on the matter, combining its knowledge in pharmaceutical regulation together with its expertise in technology, which has culminated in a highly specialized counsel advice. The client has been very satisfied with our support in this matter.
