Our Services

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Clinical Affairs

Project Management, Statistical Study Design & Analysis, Clinical Monitoring, CA & EC Submissions, Data Management, and Medical Writing Learn more

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Regulatory Affairs

Strategic Planning, Clinical Evaluation Reports, Device Approval, and Post Market Surveillance Plan, Technical Documentation Learn more

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Quality Management

Quality Systems, Design Control, Audits and Training Learn more

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Commercial Healthcare

Determination of Unique Value, Documentation of Market Potential, Clinical and Economic Evidence Learn more

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Concept & Product Development

Design Development, Prototype Manufacturing, Technology Transfer and Production Learn more

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EU Authorized Representative

EU Liason Services, Conformity Assessments, Registration, and Safety Reporting Learn more