IEC 62304 Experts in Munich
matched in minutes from over 15,000 CVsHire experts who establish software life-cycle processes, create safety-class documentation and connect IEC 62304 with ISO 13485, ISO 14971 and medical device quality systems. FRATCH matches you quickly with vetted, available freelancers who fit your project.
Meet FRATCH Experts in Munich, who have recently used IEC 62304
Peter S.
Last position:
Project Manager Camera Systems/Lenses at S&E Consulting Peter Sperber
- Management of internal and external optics, electronics, and software developers and the subproject managers throughout the entire development process up to handover to production
- Conducting RfP and contract negotiations with German, Chinese, and Japanese manufacturers and tracking the agreed deliverables
- Conducting quality gates throughout the development process
- Responsibility for meeting commercial, technical, and schedule requirements (resource and budget planning)
- Continuous monitoring of potential project risks during all phases
- Ensuring compliant development (RoHS & REACH) and documentation for worldwide CE marking
- Project status reporting to upper management and the company board
- Central point of contact for third-party contractors and their coordination in the project
Ould Aly I.
Last position:
Functional Safety Assessor at VW
- Pre-assessments and review of functional safety status for ADAS ECUs and body controller components
- Conduct functional safety audits
- Review the functional safety status of the E3 1.2 in a pre-assessment
- Document interviews
- Document findings and generate internal reports
Methods:
- ISO26262
- Automotive SPICE Level 2, 3
- Agile methods, SAFe
Tools:
- DOORS
- Enterprise Architect
- JIRA & Confluence
- IQ-FMEA
- Isograph
Jürgen H.
Last position:
iOS App Development (AI-based) at Refreco GmbH
- Development of iOS apps in Swift
- AI-supported SW development using Vibe Coding with Claude Code
- Web applications through Vibe Programming
- Use of Swift, Xcode 15, Claude Code, Proxmox, GitLab, Visual Studio Code, Cursor, Doors, ClearCase
- Use of MS Project, OpenShift, Docker, Project Server, PageMaker, CRM, MS SQL Server
- SW techniques: UML, BPMN 2.0, ERD, client/server technology
Daniel C.
Last position:
Founder & Managing Director at BotCraft GmbH
- Building the company with a focus on connectivity for IIoT and Industry 4.0, iRPA/process automation, advanced robotics and smart systems, sensors and services
- Project management and software architecture for IoT gateway development (since 2020) with protocol translation, IT/OT convergence and GRC
- Developing RPA bots for automating and monitoring industrial processes with an agent-based AI approach (since 2020)
- Implementing unsupervised clustering and anomaly detection for time series data in big data streaming pipelines (since 2021)
- Introducing a Docker-based release train for OTA updates with DevSecOps and CI/CD (since 2018)
Florin B.
Last position:
Hands-On Process Manager / Polarion System Admin at Metrax GmbH
Hands-on ALM-solution configuration: process refinement (BPMN), workshops and stakeholder management
Product development templates configuration and validation
Full traceability and decomposition
Tailored to fulfill 62304 internal SOP requirements and 29119
Regular meetings, metrics and dashboards
Work item workflows and link roles
User roles and rights
Prepared work instructions, training and rollout
Tools: Polarion (Siemens ALM), MS Visio, MS PowerPoint
Konstantin M.
Last position:
Architect, Software Developer at IPG Photonics
- Defined initial system and software architecture
- Implemented application modules and hardware control layers
- Built test and mock environments to support validation
- Developed hardware drivers and low-level communication routines
- Authored technical documentation for internal and external stakeholders
- Tools: C/C++, QML, Linux, Windows, Raspberry PI, MQTT, CAN, Serial
Discover over 15,000 top freelancers
Statistics of experts using IEC 62304
Aggregated from the professional profiles of matched freelancers.
Experience
28 years
Position duration
2.3 years
Positions per freelancer
15
Top business areas
Information Technology, Product Development, Project Management
Top industries
Information Technology, Manufacturing, Automotive
Certification focus areas
Information Technology, Product Development, Quality Assurance
Bachelor's degree or higher
100%
Master's degree or higher
80%
Doctorate
20%
Certifications per freelancer
4
Most common languages
German, English, Spanish
Speak two or more languages
100%
Based on our profile pool as of 14 Oct 2026.
Daily rate distribution
The chart shows how the daily rates of experts in this technology in Munich are distributed, based on recent contracts on our platform. Each bar covers a rate range — its height shows the share of experts charging within that range.
Average rates of experts in Munich using IEC 62304
Rates are based on recent contracts and do not include FRATCH margin.
The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.
The median daily rate is the middle value of all daily rates — half of comparable freelancers charge less, half charge more. Unlike the average, it is barely affected by outliers.
Calculated based on our freelancers’ daily rates as of 14 Oct 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
IEC 62304 experts industry focus
See which industries our matched freelancers work in most often — every figure is calculated live from the freelancers on FRATCH.
- Information Technology (100%)
- Manufacturing (100%)
- Automotive (67%)
- Healthcare (67%)
- Telecommunication (67%)
- Transportation (33%)
- Pharmaceutical (33%)
- Professional Services (33%)
Please note that freelancers can work across multiple industries, so percentages overlap.
About the technology
Medical software standard
IEC 62304 is the international standard for the life-cycle processes of medical device software. It defines expectations for planning, requirements, architecture, implementation, verification, maintenance, risk control and problem resolution. The standard applies to standalone software and software embedded in medical devices.
Safety and compliance
The standard links software activities to the safety classification of the medical device. Strong specialists translate clinical and technical risks into traceable requirements, controlled changes and documented verification evidence. They also help teams distinguish software safety work from general product development tasks.
Connected standards
IEC 62304 rarely stands alone. Professionals commonly work across ISO 14971 risk management, ISO 13485 quality management, IEC 60601-related device requirements and usability engineering under IEC 62366-1. They connect these frameworks so that hazards, requirements, tests and release decisions remain consistent.
Typical deliverables
- Software development and maintenance plans
- Safety classification and software architecture records
- Requirements, traceability and verification evidence
- Configuration, change and problem-resolution processes
- Technical documentation prepared for audits
These deliverables support medical imaging, laboratory systems, monitoring devices, digital therapeutics and software as a medical device. The exact evidence depends on the product, intended use and risk profile.
When to bring expertise
Companies often need freelance support when a product moves from prototype work into a controlled development process, when an audit exposes documentation gaps or when an existing product requires a major software change. In Munich, specialists may support local medtech teams on site while collaborating remotely with quality, regulatory and product groups elsewhere.
What strong specialists bring
Strong IEC 62304 professionals read source code and quality records with equal care. They can facilitate risk analysis, review architecture, define practical verification activities and improve traceability without creating unnecessary paperwork. Look for clear audit reasoning, experience with regulated change control and the ability to explain technical decisions to clinical, quality and regulatory stakeholders.
Frequently asked questions
Key details about IEC 62304, drawn from the questions we get asked most.
IEC 62304 defines a controlled life-cycle for medical device software. It covers planning, requirements, design, implementation, verification, maintenance, risk control and problem resolution from initial development through retirement.
IEC 62304 focuses on software life-cycle processes, while ISO 13485 addresses the broader quality management system and ISO 14971 addresses medical device risk management. A capable specialist connects the records and decisions across all three standards rather than treating them as separate files.
A strong IEC 62304 specialist often understands ISO 14971, ISO 13485, usability engineering, cybersecurity, configuration management and verification methods. Familiarity with requirements tools, issue tracking, version control and audit preparation is also valuable.
The right level of IEC 62304 experience depends on the product risk, software complexity and development stage. A small gap assessment may need focused expertise, while a new safety-critical product benefits from someone who can shape the life-cycle process and review evidence across the whole project.
IEC 62304 work is often suitable for remote collaboration because plans, requirements, traceability and verification records are digital. On-site workshops in Munich can still help when teams need to align quickly on architecture, risk controls, audit findings or release decisions.
IEC 62304 is relevant wherever software forms part of a medical device or functions as a medical device. Common settings include medical imaging, patient monitoring, laboratory equipment, connected care products and digital therapeutics.
Ask a IEC 62304 professional to explain how they would connect hazards, software requirements, architecture, tests and change records. Good specialists use proportional processes, identify missing evidence clearly and can defend technical decisions during an audit without relying on generic templates.
IEC 62304 uses software safety classes to scale the required life-cycle controls to the potential harm from software failure. The classification must be justified through the product risk analysis, and the specialist should ensure that plans, reviews, testing and documentation reflect that classification.
The average hourly rate of freelancers in Munich, Germany who have used IEC 62304 in their recent projects is 113 €, which corresponds to a daily rate of about 900 € based on an 8-hour working day.
Of the freelancers in Munich, Germany who have used IEC 62304 in their recent projects, 100% hold at least a Bachelor's degree, 80% hold at least a Master's degree, and 20% hold a doctorate.
On average, freelancers in Munich, Germany who have used IEC 62304 in their recent projects have 28 years of professional experience, with a single engagement typically lasting around 2.3 years.
The most common languages among freelancers in Munich, Germany who have used IEC 62304 in their recent projects are German (100%), English (83%), and Spanish (33%).
The most common industries among freelancers in Munich, Germany who have used IEC 62304 in their recent projects are Information Technology (100%), Manufacturing (100%), and Automotive (67%).
The most common business areas among freelancers in Munich, Germany who have used IEC 62304 in their recent projects are Information Technology (100%), Product Development (100%), and Project Management (100%).
Main locations of FRATCH Experts, who have recently used IEC 62304
Our freelancers and interim experts are at home across the DACH region — available on-site in the major business hubs or fully remote. Choose a location to discover matched specialists, local market insights and up-to-date availability.
Countries:
Berlin Hamburg 
Munich Cologne Frankfurt Stuttgart Dusseldorf Leipzig Dortmund Essen Bremen Dresden Hanover Nuremberg Request a free demo
Get in touch with the FRATCH team and we will get back to you within 4 hours.
Would you rather directly get in touch?
We always have the time for a call or email!
Philipp Thomaschewski
FRATCH CEO
