Standards training that actually changes how your team works.
IEC 60601-1, ISO 14971, ISO 13485, and IEC 62304 are not documents to be read once and filed. They are working frameworks your engineers, quality managers, and regulatory staff need to apply daily. Our training programmes are device-specific and immediately practical.
IEC 60601-1:2005+AMD1:2012+AMD2:2020 (Edition 3.2) is the foundational safety standard for electromedical equipment. Its requirements — essential performance, basic safety, protection against electric shock, mechanical hazards, temperature, radiation, and alarm systems — are supplemented by a family of collateral standards (IEC 60601-1-2 EMC, IEC 60601-1-6 Usability, IEC 60601-1-8 Alarm Systems, IEC 60601-1-9 Environmentally Conscious Design, IEC 60601-1-11 Home Healthcare, IEC 60601-1-12 Emergency Medical Services) and device-specific particular standards.
Our IEC 60601-1 training is built around the standard's risk-based approach. We start with the test structure and how the standard's requirements flow from the intended use and risk management process, then work through the most commonly misapplied clauses: applied part classification (Clause 8.7), essential performance definition (Clause 4.3), ME system documentation (Clause 16), and the interface with IEC 60601-1-2 for electromagnetic compatibility.
Training is tailored to your device type. A team developing an implantable active device will spend more time on Clauses 17–18 (radiation protection and electromagnetic compatibility of implantable devices) than a team developing bedside monitoring equipment. We adjust depth and emphasis based on your product and team background.
Full-day workshop covering standard structure, risk-based approach, applied part classification, essential performance, and test methodology. Suitable for engineers new to the standard.
Half-day focused sessions on specific challenging clauses — EMC under IEC 60601-1-2, alarm systems under IEC 60601-1-8, usability under IEC 60601-1-6 — tailored to your device.
Practical workshop on reading 60601-1 test reports: understanding test methods, identifying marginal results, and knowing what to challenge with the test laboratory.
ISO 14971:2019 (Third Edition) introduced meaningful changes from the 2007 version, including revised risk acceptability criteria, a stronger focus on benefit-risk, and updated requirements for production and post-production information. Many manufacturers are still operating risk management processes designed for the 2007 edition — which is acceptable for some legacy certifications but creates gaps in EU MDR and FDA submissions that reference the 2019 edition.
Our ISO 14971:2019 training is structured around practical application: how to define intended use and reasonably foreseeable misuse (Clause 5.2), how to identify hazards systematically (Clause 5.4), how to set and apply risk acceptability criteria (Clause 5.5), how to select and verify risk control measures (Clause 6), and how to complete the overall residual risk evaluation (Clause 7). We work through your actual device as the training case study wherever possible.
Full-day workshop covering the 2019 edition changes, practical risk analysis methods (FMEA, FTA), risk acceptability criteria design, and residual risk evaluation.
Review of your existing risk management file against ISO 14971:2019 requirements, with a written gap analysis and coaching session for the risk management team.
Design of your risk management procedure and record templates to satisfy ISO 14971:2019 and the requirements of your target regulatory markets.
IEC 62304:2006+AMD1:2015 defines the lifecycle requirements for medical device software — from software development planning (Clause 5.1) through requirements (5.2), architecture (5.3), detailed design (5.4), implementation (5.5), integration (5.6), and system testing (5.7), plus maintenance and problem resolution processes. Software safety classification (Class A, B, or C) under Clause 4.3 determines the depth of documentation and testing required.
Our IEC 62304 training is practical for software teams: what the standard requires versus what notified bodies and FDA actually look for, how to document software requirements and architecture in a way that traces to safety claims, and how to structure verification and validation activities. We also cover the interface between IEC 62304 and ISO 14971 for software-specific risks.
For quality teams new to ISO 13485:2016, we run a structured training programme covering the QMS requirements, how they differ from ISO 9001:2015, and practical implementation of design controls, purchasing controls, and corrective action processes.
Full-day or half-day workshop for your software engineering team covering classification, lifecycle documentation requirements, and verification and validation planning.
Half-day overview for teams new to medical device quality management, covering key clauses, the difference from ISO 9001, and how the QMS links to regulatory submissions.
Custom training session on any combination of IEC 60601, ISO 14971, IEC 62304, IEC 62366, or ISO 13485 designed around your team's specific knowledge gaps.
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Tell us your team size, device type, and which standards you are working to. We will design a training programme that gives your team practical, immediately applicable knowledge.
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