RiviaMed medical device regulatory consulting servicesRiviaMed

About RiviaMed

The crucial link between medical device innovators and global health authorities.

A heart rate monitor displaying a steady heartbeat, symbolizing health.

Our Mission

"Helping companies through evolving regulatory landscapes to bring safe, compliant, and effective medical devices to patients worldwide."

Our Foundation

RiviaMed was founded on the principles of excellence, unwavering professionalism, and unquestionable ethics. We understand that in the medical device sector, there is no margin for error. Our commitment to the highest standards of Quality Assurance and confidentiality is absolute. We act as a seamless extension of your team, providing the strategic guidance and meticulous execution required to transform innovative concepts into market-ready, life-changing products.

Our Team of Experts

Our core strength is a dedicated unit of principal experts with over 25 years of intensive, exclusive experience in the medical device domain.

Core Areas of Technical Expertise
  • Design Control & DHF Remediation
  • Risk Management (ISO 14971)
  • Biocompatibility (ISO 10993)
  • Software as a Medical Device (SaMD)
  • Software Validation (IEC 62304)
  • FDA Quality Management System Regulation (QMSR)
  • EU Medical Device Regulation (MDR)
  • EU In Vitro Diagnostic Regulation (IVDR)