REGULATORY SERVICES
Psephos has decades of experience obtaining regulatory approvals for medical devices. We help clients develop a regulatory strategy with an action plan, which we can help implement.
Services include:
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Regulatory Strategy
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Device Classification
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UKCA Marking
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CE Marking
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Technical File Preparation, Gap Analysis and Updates
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Notified and Approved Body Selection
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Determining Device Testing Requirements
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Assistance with Engaging and Selecting Test Houses
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Executive Level Regulatory Coaching
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FDA Guidance