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Brighton, United Kingdom
Category:
Healthcare Compliance/MedTech Regulatory Advisory
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Address details
12-16 Marlborough Place, Brighton, East Sussex, BN1 1WN, United Kingdom
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Business hours
Monday – Saturday: 9:00 AM – 5:30 PM
Sunday: Closed
Info
8fold Governance is a specialized advisory firm providing comprehensive healthcare compliance and regulatory support with a "human touch." Focused on accelerating the market entry of MedTech, Digital Health, and Medical Service innovators, the firm offers expert guidance on complex requirements including AI Governance, ISO certifications (13485, 27001), and NHS Digital Technology Assessment Criteria (DTAC). By managing the intricate details of information governance, clinical safety (DCB0129/0160), and CQC registration, the team enables healthcare pioneers to navigate the path from product development to successful clinical adoption while ensuring the highest standards of product and business quality.