Medical Devices
The Problem
The global medical device market is projected to exceed $800 billion by 2030, yet many manufacturers continue to rely on outdated, manual systems to track product data, compliance testing, and regulatory submissions. This introduces major risks:
Inconsistent documentation across design, testing, and manufacturing systems
Gaps in QA traceability that delay audits or trigger recalls
Difficulty proving conformity with ISO 13485, MDR/IVDR, and FDA requirements
Manual logs and spreadsheets that lack integrity, versioning, or secure signatures
For regulators, missing data or unverifiable records make post-market surveillance difficult. For manufacturers, each compliance failure risks millions in product holds, reputation loss, or denied market entry.
Circular's Solution
Circular creates a cryptographically verifiable compliance layer for medical devices from design to deployment:
Immutable certification of design history files (DHF), risk files, and technical documentation
Anchor QA and production test logs to the blockchain for traceability
Certify software and firmware updates, including SaMD/AI modules
Real-time audit logs for conformity assessments, inspections, or notified body reviews
Compatible with ISO 13485, ISO 14971, MDR, IVDR, and FDA 21 CFR Part 820
Every change is time-stamped, signed, and linked to authorized personnel or systems—eliminating ambiguity during audits or in the event of product failures.
How It Works (Example Flow)
Engineer uploads a new DHF revision or device log
Circular certifies and timestamps the file, storing the hash on-chain
QA or compliance team reviews and signs off with their digital ID
Full audit log and version trail is available for regulators or notified bodies
Outcomes
Accelerates audit readiness and reduces inspection preparation time
Prevents recall-related fines by enabling instant traceability and compliance logs
Reduces documentation errors and version mismatches across large teams or OEM suppliers
Strengthens global regulatory compliance, simplifying CE mark, FDA 510(k), or MDR approval
Benefits by Stakeholder
QA/Compliance Teams: Real-time traceability, fewer audit disruptions
Regulators: Faster, clearer access to immutable evidence
Manufacturers: Reduced risk, faster product clearance, stronger market access
End Users: Higher assurance of product safety and accountability
Circular gives the medtech industry the modern compliance infrastructure it urgently needs—without disrupting existing tools or QMS platforms.
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