We, Rescisco Global Regulatory consultants, intended to offer quality and regulatory services to the manufacturers of medical devices including in-vitro diagnostic medical devices from conceptualization stage to marketing as per the requirements.

Trainings & Qualification

  • Indian Medical Device Regulations (IMDR)
  • Risk Management System for Medical Devices
  • US FDA Medical Device Regulations
  • ISO 13485:2016- Quality Management System for Medical Devices
  • EU MDR 2017/745 & 2017/746
  • ISO 60601
  • ISO 62304
  • ISO 11607
  • ISO 14155
  • MDSAP