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global medical device market is projected to exceed $800 billion by 2030, yet many manufacturers continue to rely on outdated, manual systems to track product data, compliance testing, and regulatory submissions.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)

1. Engineer uploads a new DHF revision or device log

2. Circular certifies and timestamps the file, storing the hash on-chain

3. QA or compliance team reviews and signs off with their digital ID

4. 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.