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
Consulting

Assessing your regulatory needs

Interfacing with regulatory authorities on your behalf

Post-market compliance activities

And more

 

quality compliance services

 

Quality Compliance
Services

Quality program development and implementation

Verification/validation of systems and manufacturing processes

Auditing and remediation

And more

 

 computer systems validation

 

Computer Systems
Validation

Validation of software integrated with devices, instrumentation or diagnostics

Testing services

Systems design and implementation

And more