Medical device regulatory consulting services
We are the only medical device regulatory consulting company with presence in over 140 countries, offering a wide range of compliance services, including regulatory strategy, device registration, quality management system compliance, and in-country regulatory representation. We offer our clients a single source for regulatory compliance help, whether they are selling in one market or dozens of countries around the world. The size of our global team means we have deep expertise with a variety of market requirements and device types.
Explore our consulting services
Clinical Evaluation Report (CER) preparation
Human Factors Consulting(HFE)
EU MDR 2017/745 gap assessments and transition consulting
ISO 13485 and QMS compliance
Risk management planning and ISO 14971 implementation
UDI compliance consulting
Certificate of Free Sale (CFS) for Medical Device Exports
CRO Services
Post marketing Survelliance
Technical file preparation
MDSAP Consultation
Human Factors Consulting(HFE)
EU MDR 2017/745 gap assessments and transition consulting
ISO 13485 and QMS compliance
Risk management planning and ISO 14971 implementation
UDI compliance consulting
Certificate of Free Sale (CFS) for Medical Device Exports
CRO Services
Post marketing Survelliance
Technical file preparation
MDSAP Consultation
