IEC 62304 Gap Analysis
Professional IEC 62304 gap analysis and implementation of medical software. Identify gaps in the standard, improve compliance, and prepare your product for audits.
Their result: a clear, prioritized action plan.
Our IEC 62304 gap analysis delivers:
Complete assessment of all standard chapters
From safety classification to requirements, architecture, integration, system testing, maintenance & problem resolution
Clear fulfillment assessment
Fulfillment rating: Fulfilled / Partially fulfilled / Not fulfilled
Based on your documentation & development organization
Identified gaps with understandable explanations
Competent, precise and compliant with standards (e.g. traceability gaps, incomplete planning, missing processes).
A concrete and implementable action plan
Including responsibilities, prioritization, acceptance criteria and required artifacts, development plan, traceability matrix, security concept).
This approach corresponds to our proven methodology in customer projects.
Optional: Implementation of the measures by our team
If desired, we can assist with:
- Complete document creation,
- Architectural revision,
- Risk File Extensions,
- Introduction of the 62304 compliant development process (based on our process instructions & QMS).
Why become a MEDtech engineer?
- 17+ years of experience in regulated development projects
- Development of Class IIa–III systems
- Structured sales and distribution strategies including traceability
- Thorough risk analyses in accordance with ISO 14971
- Project experience in an international environment
You can find our full range of services here: Software development for medical devices
- Active development engineers, not just documentation consultants
- Regulatory requirements implemented in a technically sound manner
- Integration into existing development teams is possible
- Focus on realistic, implementable solutions
- Understanding of time, budget and resource constraints
Feel free to visit our specialist blog for further practical insights: MEDtech Engineer Blog
- Certified QMS according to EN ISO 13485
- IEC 62304 (Software Lifecycle)
- IEC 60601-1 /-1-2 /-1-6 (electrical safety)
- IEC 81001-5-1 (Cybersecurity)
- ISO 14971 (Risk Management)
- Experience with MDR & international regulatory requirements
- Hardware, software and systems engineering under one roof
- Safety & Cybersecurity integrated into the architectural design
- Interface management between disciplines
- Holistic consideration across the entire product life cycle
- Established development and review processes
- Proven templates & documentation standards
- Clear roles and responsibilities
- Fast decision-making processes
- Efficient coordination with QM and Regulatory
Who is our IEC 62304 gap analysis ideal for?
- Manufacturers of active Medical Device Software (MDS)
- Startups with a software component
- Companies shortly before audit or certification
- Companies that take over documents from previous projects
- Teams using Safety-Class-C software (high documentation requirements)
- Projects with a high proportion of networked software / cybersecurity requirements
Our approach – clear, efficient & transparent
- Kick-off & document review
(Software development plan, architecture, requirements, risk file, test documentation, etc.) - Complete gap analysis according to IEC 62304
- Review workshop with your experts
- Audit-proof final report
- Optional: Implementation of all measures
References
"MEDtech Ingenieur supported anvajo with reviews of software and cybersecurity documentation. The collaboration was consistently professional, structured, and efficient. We particularly appreciated their practical approach and high level of regulatory expertise."
- anvajo GmbH
Your contact person for software gap analyses
