The Customer is a US based software company who recently involved in medical device industry to develop software for clinical study and patient enhanced experiences. They are seeking a quality and regulatory consultation support for FDA and CE compliance while they developing variety for software to be used either alone or in conjunction with other...
Services We Provide and Markets We Support
Medical Device Registration
Regulatory Strategy, Health Authority Meetings, Product Registration, Regulatory Assessment and Intelligence
Quality ManagementHelping companies develop, implement, and maintain compliant quality management systems (QMS)
U.S. FDA Agent
- Compliance & Enforcement
- Product Development
- Local Agent Representation
- Regulatory Information Technology Systems Selection & Implementation
- Global Program and Project Management (Pharma and Device)
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Understanding regulatory systems in emerging markets goes beyond reading regulations, by doing, through each registration, each product testing, and each consultation with officials and reviewers. Take advantage of our experiences and gain your regulatory approval the RIGHT way.
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