Regulatory
Developing a medical device?
Need UKCA or CE marking?
Need FDA submission support?
Psephos has decades of experience obtaining regulatory approvals for medical devices of all risk levels (Class I through to Class III) and ranging from cardiovascular implants to digital health; from IVDs to AI; from early stage to multi-national. We help clients develop a regulatory strategy with an action plan, which we can help implement.
Regulatory Services to Help Navigate Your Journey:
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Regulatory strategy analysis and development
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Medical device/IVD regulation gap analysis
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Technical documentation preparation and updates
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Device classification
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Device registration
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UKCA and CE marking
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Transitioning from MDD to MDR compliance
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Determining device testing requirements
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Assistance with engaging and selecting test houses
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FDA submissions and clearance
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Executive level regulatory coaching
