Medical Devices & Diagnostics

Medical Devices & Diagnostics covers instruments, implants, in-vitro diagnostics, and the software that increasingly is the device (SaMD). Quality is built through design controls, risk management, and a lifecycle that runs from design and verification to post-market surveillance — a different centre of gravity from batch-based pharma.

Governed by FDA (21 CFR 820, transitioning to the QMSR harmonised with ISO 13485; plus 21 CFR 803 device reporting), the EU MDR/IVDR, and the ISO/IEC standards — ISO 13485 (QMS), ISO 14971 (risk), IEC 62304 (software), and IEC 60601 (electrical safety). Notified bodies and unique device identification are central to market access.

A traceable design history file and an ISO 14971 risk-management process that ties hazards to mitigations and verification — the core of device quality.

IEC 62304 software life cycles and computer-software-assurance thinking for software that is, or is in, the device — the fastest-growing device risk area.

An ISO 13485 QMS (and the FDA QMSR that harmonises with it) covering design, production, CAPA, and supplier control across the device lifecycle.

Complaint handling, medical device reporting (21 CFR 803, MDR/IVDR vigilance), and post-market clinical follow-up that close the loop after launch.

• ›Design-control and risk-management gaps that surface as field failures
• ›Software defects and cybersecurity vulnerabilities in connected devices
• ›Late or missed adverse-event (MDR) reporting
• ›Unapproved design changes or shipping without required clearance

Derived from the 13 standards SPEQ decodes for this industry.