Medical Devices
For med-device manufacturers, validation and clinical evaluation share the same DNA: traceable claims, controlled documents, and defensible audits. Cybroscape covers both — GxP Copilot for QMS / eQMS / MES validation, TraceDraft for CERs and post-market surveillance documentation.
Medical device manufacturers work under EU MDR or IVDR and, for the US market, FDA QSR. Alongside computerised system validation this adds obligations with no direct pharma equivalent: clinical evaluation that is continuous rather than one-time, and post-market surveillance feeding back into it. Software as a medical device carries its own lifecycle under IEC 62304.
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Regulations We Cover
Every medical device engagement is mapped to the regulations your inspectors will use.
devices
- EU MDR / IVDR
- FDA QSR / 21 CFR 820
- ISO 13485
- IEC 62304
- FDA AI/ML SaMD guidance
- 01Design and developmentPLMALMDesign controls and traceability
- 02Device softwareALMTest toolsAn IEC 62304 software lifecycle
- 03ManufacturingMESERPDevice history records
- 04Quality systemeQMSDocument managementISO 13485 and FDA QMSR records
- 05Post-marketComplaint handlingVigilance reportingComplaints, vigilance and trends
Services & Products For Medical Devices
- CSV
- AI Validation
- CER
- Design Controls Traceability
- eQMS Implementation
AI/ML validation for a SaMD manufacturer
A Class II SaMD manufacturer had an ML-based clinical decision-support module ready to ship, but no defensible AI assurance stack.
Read the case studyEU MDR Article 61 and the Clinical Evidence Burden
EU MDR Article 61 requires that every medical device placed on the European market is supported by clinical evidence — data demonstrating that the device performs as intended and that its benefits outweigh its risks when used as directed. For Class IIb and Class III devices, this means a Clinical Evaluation Report (CER) that meets the Annex XIV requirements: systematic literature search, clinical evaluation plan, equivalence assessment or clinical investigation data, post-market clinical follow-up plan, and summary of safety and clinical performance for implantable and Class III devices.
The clinical evidence burden under EU MDR is significantly higher than under MDD. Equivalence claims are harder to sustain: the manufacturer must demonstrate technical, biological, and clinical equivalence to a specific predicate device, and the MDR requires contractual access to the predicate device's technical documentation — an obligation that is practically impossible to meet for third-party devices. For most Class IIb and III manufacturers, EU MDR compliance requires either generating new clinical data or substantially expanding the literature-based evidence package.
IEC 62304 Software Lifecycle for Medical Device Software
IEC 62304 specifies the software development lifecycle requirements for medical device software, including Software of Unknown Provenance (SOUP). Its safety classification system — Class A (no injury or damage), Class B (non-serious injury), Class C (serious injury or death) — drives the depth of lifecycle documentation required. Class C software requires the full complement of IEC 62304 deliverables: software development plan, requirements analysis, architectural design, detailed design, implementation, unit testing, integration testing, and system testing, with maintenance processes for managing software problem reports and change requests.
SaMD — Software as a Medical Device — adds a layer of complexity because the software is the device, not a component of it. FDA's 2019 AI/ML-based SaMD action plan and the IMDRF SaMD framework create a validation and governance challenge that existing IEC 62304 implementations were not designed to address: how do you maintain a frozen, version-controlled device when the AI component is continuously learning and improving? The answer involves a Predetermined Change Control Plan (PCCP) that describes the types of changes the manufacturer anticipates, the testing and validation they will apply before implementing each change, and the monitoring plan that confirms the change performs as expected in the field.
eQMS Validation for ISO 13485 and 21 CFR Part 820
Medical device quality management systems require both a QMS that meets ISO 13485 and 21 CFR Part 820, and a validated electronic QMS platform that manages the QMS records in compliance with 21 CFR Part 11 and EU MDR Annex IX. The eQMS is often the most complex computerised system in a medical device manufacturer's validated estate: it manages design controls (DHF, DMR, DHR), CAPA, complaint handling, supplier management, and training — all of which are directly inspected during FDA QSR inspections and Notified Body MDR audits.
Cybroscape's eQMS validation practice covers the major platforms deployed in medical device environments: Greenlight Guru, MasterControl, Veeva Vault Quality, and ETQ Reliance. For each platform, we deliver a configuration specification aligned to the manufacturer's ISO 13485 QMS, a validated deployment with IQ/OQ/PQ documentation, and an ongoing change management framework that maintains validation status as the eQMS evolves. GxP Copilot provides the AI-assisted validation lifecycle management that keeps the eQMS validation current without requiring a full revalidation for every configuration change.
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