Medical Devices
The Problem
The global medical device market is projected to exceed $800 billion by 2030, yet many manufacturers still rely on outdated, manual systems to track product data, compliance testing, and regulatory submissions.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 can mean product holds, delayed approvals, costly remediation, reputational damage, or denied market entry.
Circular's Solution
Circular provides a blockchain-anchored certification layer for medical device compliance from design through post-market oversight, without requiring manufacturers to replace their existing QMS, PLM, or manufacturing systems. It enables:
Tamper-evident certification of design history files (DHF), risk files, and technical documentation
Traceable anchoring of QA and production test logs with verifiable timestamps and signer identity
Certification of software and firmware releases, including SaMD and AI-related artifacts where applicable
Real-time audit trails for conformity assessments, inspections, and notified body reviews
Support for workflows aligned with ISO 13485, ISO 14971, MDR, IVDR, and FDA 21 CFR Part 820 expectations
Each certification event is time-stamped, signed, and linked to an authorized account or system, creating a clear chain of evidence for audits, investigations, and incident response.
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 Protocol provides the medtech industry the modern compliance infrastructure it urgently needs, without disrupting existing tools or QMS platforms.
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