Medical Device and Life Sciences Engineering
Mastering medical device complexity and regulatory compliance - securing ISO 14971 and IEC 62304 outcomes through rigorous, model-based risk management and RAAML.
Medical device development is governed by strict mandates for lifecycle traceability and risk management. ISO 14971 and IEC 62304 require systematic hazard analysis and software lifecycle controls that are increasingly difficult to sustain within document-based systems. Relying on disconnected files creates significant risks for patient safety and often leads to costly delays.
Enola provides the model-based infrastructure required to turn compliance into a natural byproduct of engineering. By applying RAAML and structured risk management from the earliest stages, we build the required traceability record directly into the design process. This eliminates the burden of manual documentation, ensuring that safety and effectiveness are validated by an authoritative digital source of truth.
Capabilites
How Enola Supports Medical Device Organizations
01/06
ISO 14971 Risk Management
Systematic risk management within CATIA Magic using RAAML - hazard identification, risk estimation, risk acceptability evaluation, and risk control specification. Full traceability from hazard through design control and verification evidence.
02/06
FMEA and Fault Tree Analysis
Failure Mode and Effects Analysis and Fault Tree Analysis for medical devices - modelling failure modes, effects, and detection mechanisms within the CATIA Magic Safety and Reliability Analyzer for systematic coverage assessment.
03/06
IEC 62304 Software Lifecycle
SysML-based system and software architecture modelling aligned to IEC 62304 software development lifecycle requirements - software item identification, requirements allocation, architecture specification, and verification traceability.
04/06
Requirements Traceability for Regulatory Submission
End-to-end requirements traceability from stakeholder needs and regulatory requirements through system and software design - supporting 510(k) documentation, technical file preparation, and post-market surveillance planning.
05/06
Connected Health Architecture
SysML architecture modelling for connected medical devices - interface specification, data security architecture, and interoperability with electronic health record systems.
06/06
MBSE Training for Medical Device Teams
Instructor-led SysML and CATIA Magic training for medical device engineering teams - including domain-specific exercises applying MBSE methodology to device development in the context of ISO 14971 and IEC 62304.
INSIGHT
MBSE in Practice - Medical Device & Life Sciences
MIT remote patient monitoring (MIT, 2020)
Research published by MIT demonstrates MBSE applied to medical device design for remote patient monitoring, with hardware, embedded software, wireless connectivity, data security, and clinical workflow integration managed in a single connected model. Changes propagate, requirements stay traceable, and the audit trail that regulatory submission requires is generated from the architecture rather than assembled manually.
STANDARDS
Regulatory and Standards Landscape
Application of risk management to medical devices. Enola implements HARA-style hazard analysis, risk estimation, and risk control architecture within CATIA Magic using RAAML — producing traceability artefacts suitable for technical file and 510(k) submission.
Risk Assessment and Analysis Modeling Language — the OMG standard for safety and reliability analysis within MBSE models. Enola's CATIA Magic RAAML capability covers FMEA, FTA, and safety coverage analysis.
Medical Device Software — Software Lifecycle Processes. Enola's SysML-based system and software architecture modelling supports IEC 62304 lifecycle process alignment and software item traceability.
Requirements traceability and design documentation support for FDA 510(k) submissions and EU MDR Technical File preparation — producing structured, auditable evidence from the model.
Quality Management Systems for medical devices. Enola's engineering process and documentation approach aligns to ISO 13485 quality management requirements.
Connected health platform architecture incorporating data security requirements — encryption, access controls, and audit logging — within the SysML system architecture model.
Enola's medical device engagements cover connected medical devices, diagnostic platforms, and software-intensive devices operating under FDA oversight and international regulatory requirements, including EU MDR.
"ISO 14971 requires risk management to be applied throughout the entire device lifecycle - from the earliest hazard identification through to post-market surveillance. A model-based approach builds this traceability into the engineering process from the start, so the evidence required for regulatory submission is generated as the design develops."
Working With Enola in Life Sciences
Medical device engagements typically focus on risk modelling, lifecycle alignment, and specialized SysML training. For organizations approaching 510(k) or EU MDR milestones, Enola leverages RAAML and automated traceability to generate regulatory evidence directly from the model - eliminating redundant documentation efforts.
Contact Enola to discuss your device program's current stage and regulatory pathway.