Medical Devices & Diagnostics
Medical devices, IVDs, and device software — design controls, risk management, and post-market surveillance.
What this page does not claim
SPEQ decodes published standards and does not determine which apply to your product. An industry’s counts measure SPEQ’s coverage, not the size of its rulebook.
WHAT THIS INDUSTRY COVERS
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.
REGULATORY LANDSCAPE
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.
WHY THIS PRODUCT IS HARD TO CONTROL
A device is used rather than consumed, and the user is part of the system. It is operated, sometimes for years, often by someone under pressure and occasionally by someone who has never read the instructions — so a design that is correct and confusing fails in the field exactly as a design that is wrong. That is why the regulation centres on design controls and human factors rather than on batch conformity, why risk management is a lifecycle activity under ISO 14971 rather than a pre-market document, and why post-market surveillance carries weight the pharmaceutical equivalent does not.
WHAT QUALITY MEANS HERE
Design controls & risk management
A traceable design history file and an ISO 14971 risk-management process that ties hazards to mitigations and verification — the core of device quality.
Device software (SaMD)
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.
The quality management system
An ISO 13485 QMS (and the FDA QMSR that harmonises with it) covering design, production, CAPA, and supplier control across the device lifecycle.
Post-market surveillance & vigilance
Complaint handling, medical device reporting (21 CFR 803, MDR/IVDR vigilance), and post-market clinical follow-up that close the loop after launch.
STANDARDS SPEQ DECODES · 42
Open the full library →WHERE QUALITY FAILS
- 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
Medical Devices & Diagnostics: frequently asked questions
Quick answers to common questions about GxP in Medical Devices & Diagnostics.
What quality management system applies to medical devices?
ISO 13485 is the international device QMS standard. In the US, FDA’s 21 CFR 820 is transitioning to the Quality Management System Regulation (QMSR), which harmonises with ISO 13485; the EU MDR and IVDR set the parallel European requirements.
What is Software as a Medical Device (SaMD)?
SaMD is software intended for a medical purpose that performs that purpose without being part of a hardware device. Its lifecycle is governed by IEC 62304, and FDA’s computer-software-assurance thinking increasingly applies to it — the fastest-growing device risk area.
What are design controls in medical devices?
Design controls are the traceable process — captured in a design history file — that links user needs and hazards to design inputs, outputs, verification, and validation. They are paired with an ISO 14971 risk-management process and sit at the core of device quality.