Regulatory and Quality Services for Medical Devices

Expert insight and clarity to increase speed to market



  Medical Device Compliance Regulatory


Safis Solutions works with medical device companies around the world to meet regulatory and quality standards expected by global health authorities. With field experience in over 40 countries, our consultants navigate companies through the complex and continuously changing regulatory processes to ensure that their products launch as soon as possible.


Your product has the power to change lives for the better – but first you need to get to market. Safis Solutions can help guide you through the process.



 regulatory compliance consulting


Regulatory Compliance

Assessing your regulatory needs

Interfacing with regulatory authorities on your behalf

Post-market compliance activities

And more


quality compliance services


Quality Compliance

Quality program development and implementation

Verification/validation of systems and manufacturing processes

Auditing and remediation

And more


 computer systems validation


Computer Systems

Validation of software integrated with devices, instrumentation or diagnostics

Testing services

Systems design and implementation

And more