IEC 62304 Experts in Germany
to deliver compliant medical software, matched in minutes with AIHire experts who plan software safety classifications, maintain lifecycle documentation and support verification activities under IEC 62304. FRATCH connects you quickly with vetted, available freelancers whose experience matches your medical device project.
Meet FRATCH Experts in Germany, who have recently used IEC 62304
Jens R.
Last position:
Platform Architect & Senior Developer at Direct client, industrial measurement technology, medium-sized company
- Technical leadership across hardware, firmware, and software teams; scope: hardware/firmware team (4 people) and leadership group (5 people)
- Consolidated and documented a product family that had grown over more than 15 years and aligned it with CRA compliance — from the bare-metal I/O module to the cloud interface.
- Provided the most important customer product with the essential requirements and architecture documentation within two months — for a firmware landscape that had grown over more than 15 years. It now supports the customer’s modernization strategy.
- Established a monthly reporting line to the supervisory board and executive board within three months: nine meetings since 12/2025. The report itself is versioned and built from the CI pipeline; it is based on automatically collected activity and release data instead of assessments.
- Built a container-based CI/CD infrastructure from scratch: cross-compilation, host tests, and documentation builds in one continuous pipeline.
- Introduced declarative QA gates for DevOps and development artifacts — from the start using lefthook instead of pre-commit, executed in a dedicated container image.
Technologies used: arc42, req42, tpo42, docToolchain, PlantUML, ArchiMate, C4 model, ADR, C, C++ (GTest), CMake, Bare Metal (ARM Cortex-M3/M7), OCI containers, Jenkins, lefthook, Prometheus, Grafana, SBOM, CRA, OPC, SCADA, PLC integration, IPv6 migration, Zero Trust, Sociocracy 3.0, Cynefin
Andreas S.
Last position:
Consulting on quality management and regulatory affairs at Curevius GmbH
Manufacturer of medical devices
- Creation and further development of quality management systems according to EN ISO 13485
- Gap analysis of existing quality management systems according to ISO 13485
- Consulting and support in customer projects in the field of quality management and
- Proof of regulatory compliance for medical devices of all risk classes
- Preparation of technical documentation according to MDR
- Gap analysis of the risk management file according to ISO 14971:2019
Torsten V.
Last position:
COO/CTO (Freelance) at Reitreal LLC
- Setting up and running operations for offering multi-level tokenized real estate investment possibilities,
- Start-up preparations, establishing a real estate investment trust (REIT)
- Communication with SEC, technology provider selection, etc.
Denys Z.
Last position:
Technical Writer at Omilia Natural Solutions
- Creation of technical documentation for conversational AI products
- Development of user and API manuals (JSON, Markdown)
- Use of Git, Jira, Confluence for version control and task tracking
- Collaboration with engineers and PMs for accurate content
Kai W.
Last position:
biobedded systems GmbH
- Embedded software development for EMS safety boards in medical technology according to IEC 62304 / ISO 13485
- Technologies: C++, OpenCV, Python, Qt6, JTAG, UART, CMake, IEC 62304, ISO 13485
Maher K.
Last position:
Executive Management, Managing Partners at HMM Diagnostics GmbH
- Detailed information in the reference projects file
- Responsibility for the strategic and operational management of the company
- Leading and coordinating product development projects in the areas of e-health and medical technology
- Freelance project management activities in various industries, including IT and medical technology
- Introduction of innovative products and solutions in medical technology, connectivity and fitness in international markets
- Building platforms for e-health and corporate health management
- Introduction and migration of ERP systems (SAP Business One, JTL WaWi) in sales- and production-oriented companies
- Project management for international and cross-company projects
- Crisis management and successful control of critical projects
- Support of IT infrastructure including server landscapes and SAN systems
- Consulting for international company founders
Unnikuttan V.
Last position:
Managing Director (Co-Founder) at AathmaSignals
- Spearheading investor outreach and partnership development as founding MD, building the business case and technical narrative needed to attract initial funding and strategic collaborators in the digital health space
- Designing multi-agent AI systems for autonomous biosignal analysis, orchestrating LLM-based reasoning pipelines with domain-specific medical context to enable intelligent, clinical decision support
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
Oleksii K.
Last position:
Software developer (freelance) at Sasse Elektronik GmbH
- Built custom Yocto Linux image with Docker support (NXP i.MX 6ULL)
- Developed distributed Python application (web interface, gas/temp control)
- Designed multiple docker containers for production and development
- Wrote documentation per IEC 62304
Thomas A.
Last position:
Interim Management at Vincorion Power Systems GmbH
- Process and project management to optimize products and development processes for energy systems
- Technical risk management
- Requirements engineering and system architecture
- System FMEA of power generator units and energy storage modules aiming for generic structures
- Claims management according to Section 313 of the German Civil Code
- Regulatory environment: military and NATO standards, AQAP, VG norms
Cesar S.
Last position:
Lead Cloud Engineer at Charge-V GmbH
- Responsible for setting up and configure AWS Organizations and Control Tower on company's master organizational account
- Administer and maintain various AWS services, including EC2, S3, RDS, Lambda, VPC, IAM, etc.
- Monitor system performance, availability, and capacity planning to ensure scalability and reliability
- Implement and maintain infrastructure as code (IaC) using tools like CloudFormation or Terraform
- Work closely with development and operations teams to automate deployment processes using CI/CD pipelines (e.g., Jenkins, GitLab CI/CD)
- Develop and maintain scripts for automating routine tasks and infrastructure provisioning
- Implement automation for monitoring, logging, and alerting to ensure timely incident response
- Implement and enforce security company guidelines and best practices for AWS environments
- Configure and manage AWS security services such as AWS Identity and Access Management (IAM), AWS WAF, AWS Shield, etc.
- Collaborate with the Security Team to improve and update security policies and posture
- Collaborate with development teams to provide agile deployments and optimize application performance and reliability on AWS
- Provide technical support and guidance to internal teams on AWS-related issues and best practices
- Participate in cross-functional projects to enhance overall infrastructure and operational efficiency
Faruk S.
Last position:
Software Developer at HR Solutions GmbH
- Designing and developing a web application for the public sector
- Setting up and executing software tests, mainly unit tests
- Technical design and implementation of requirements
- Uploading and displaying CSV files
- Communicating with business units regarding development and test support
- Technologies used: Java, Spring Boot, Spring Security, Spring Batch, Spring Cloud, Spring Data JPA and Hibernate, RESTful, JSON, React, Oracle, JUnit, Mockito, CI/CD, GitLab, Docker, Keycloak, Liquibase, BIRT, Swagger, Microservices
Monika W.
Last position:
Quality Specialist at Nexans GmbH
- Implementation of a quality management system including creating all required process descriptions and work instructions for ISO 9001:2015 certification, as well as final planning and conducting audits
- Creating action catalogs for measures needed to comply with ISO 9001 and achieve the targeted certification
- Preparing documentation related to ISO 9001
- Developing training materials for employees and managers based on the QMH and the created documentation
- Recording results of external audits of departments (incoming goods, production, warehouse logistics, procurement and supplier management, outgoing goods, shipping) according to ISO 9001
- Preparing for and participating in certification audits
Elena C.
Last position:
Plant Quality Manager at BHC Gummi-Metall GmbH
- Reviewing customer requirements (Quality Agreements) and implementing process and product quality measures within the approval processes (start-up support and initial samples according to PPF/PPAP) under APQP
- Main contact for quality-related issues at the site
- Implementing supplier quality support and development
- Ensuring compliance with all quality-specific requirements such as incoming and outgoing inspections, initial sample test reports, quality work instructions, inspection plans, and control charts
- Customer contact for complaint management and handling using Quality Core Tools: 8D report, 5 Why, Ishikawa analysis
- Active use of quality tools: control plan, PFMEA, inspection plan, EMPB, drawings, collecting and analyzing statistical data, R&R, MSA, SPC
- Conducting internal system, product and process audits according to VDA 6.3 and VDA 6.5
- Responsible for certification of the quality management system IATF 16949, occupational health and safety ISO 45001, and environmental management ISO 14001
- Supervising, goal-oriented leadership and development of a 10-member team
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
Discover over 15,000 top freelancers
Statistics of experts using IEC 62304
Aggregated from the professional profiles of matched freelancers.
Experience
24 years
Position duration
1.9 years
Positions per freelancer
15
Top business areas
Information Technology, Quality Assurance, Product Development
Top industries
Healthcare, Information Technology, Manufacturing
Certification focus areas
Information Technology, Product Development, Project Management
Bachelor's degree or higher
84%
Master's degree or higher
56%
Doctorate
4%
Certifications per freelancer
4
Most common languages
German, English, French
Speak two or more languages
100%
Based on our profile pool as of 19 Sep 2026.
Daily rate distribution
The chart shows how the daily rates of freelancers in this technology in Germany are distributed, based on recent contracts on our platform. Each bar covers a rate range — its height shows how many freelancers charge within that range.
Average rates of experts in Germany 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 19 Sep 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.
- Healthcare (93%)
- Information Technology (81%)
- Manufacturing (81%)
- Automotive (52%)
- Energy (33%)
- Telecommunication (30%)
- Transportation (26%)
- Aerospace and Defense (22%)
Please note that freelancers can work across multiple industries, so percentages overlap.
About the technology
Purpose and scope
IEC 62304 is the international standard for the lifecycle of medical device software. It defines processes for planning, requirements, architecture, implementation, verification, maintenance, risk management and problem resolution. The standard applies to standalone software and software embedded in medical devices.
Safety classification
The standard links lifecycle controls to the software safety classification. Strong specialists help teams justify the classification, define suitable controls and keep safety decisions aligned with the device risk management process. They also distinguish software items, interfaces and external components that can affect patient or operator safety.
Lifecycle deliverables
Projects commonly use IEC 62304 to create and maintain:
- Software development and maintenance plans
- System and software requirements specifications
- Architecture, detailed design and traceability records
- Verification plans, test evidence and release documentation
- Configuration, change and problem-resolution records
Ecosystem and interfaces
IEC 62304 work connects closely with ISO 14971 risk management, IEC 60601 where electrical medical equipment is involved, and usability engineering under IEC usability standards. Specialists may also work with quality management systems, cybersecurity processes, clinical evaluation inputs, automated testing, version control and requirements tools. The goal is consistent evidence across technical and quality records.
When companies need help
Companies often bring in freelance expertise when a product moves toward a formal submission, when an audit exposes gaps, or when legacy software lacks traceability. Support is also useful during major changes, supplier transitions and remediation projects. In Germany, remote collaboration is common, while regulated teams may still need occasional on-site workshops and clear German or English documentation.
What strong specialists bring
A capable professional combines practical software lifecycle knowledge with medical device quality experience. They can turn vague product needs into testable requirements, challenge incomplete risk controls and explain technical decisions to auditors and cross-functional teams. Look for evidence of maintained documentation, resolved findings and verification that reflects the actual product rather than a template.
Frequently asked questions
Questions about IEC 62304? Start with the answers below.
IEC 62304 defines a controlled lifecycle for medical device software. It helps companies plan development, manage software safety risks, document requirements and design, verify releases, control changes and maintain the software after deployment.
IEC 62304 governs the software lifecycle, while ISO 14971 focuses on risk management for medical devices. They work together: software hazards and controls identified through risk management must be reflected in software requirements, design, verification and maintenance activities.
An IEC 62304 specialist should understand ISO 14971, quality management systems and relevant medical device submission processes. Useful adjacent skills include requirements traceability, software testing, cybersecurity, configuration management and audit preparation.
IEC 62304 expects lifecycle controls to reflect the software safety classification and project context. A capable specialist can scale planning, independence, verification evidence and documentation without removing controls required for safety.
IEC 62304 activities are often suitable for remote collaboration because requirements, plans, test evidence and traceability records are managed digitally. On-site workshops may still help with product reviews, quality-system alignment or discussions with German-speaking stakeholders.
Ask an IEC 62304 freelancer to explain how they handled safety classification, traceability, verification independence and change control on a real product. Strong answers connect documents to actual software behavior and show how findings were investigated and closed.
IEC 62304 is relevant to software that functions as a medical device as well as software embedded in medical equipment. Its lifecycle approach can support products such as diagnostic applications, monitoring software and therapy-related systems, alongside applicable regulatory requirements.
An IEC 62304 specialist can identify missing links between risks, requirements, tests and release records. They can also structure remediation plans, improve change control and prepare coherent evidence when an audit or submission reveals lifecycle gaps.
The average hourly rate of freelancers in Germany who have used IEC 62304 in their recent projects is 107 €, which corresponds to a daily rate of about 855 € based on an 8-hour working day.
Of the freelancers in Germany who have used IEC 62304 in their recent projects, 84% hold at least a Bachelor's degree, 56% hold at least a Master's degree, and 4% hold a doctorate.
On average, freelancers in Germany who have used IEC 62304 in their recent projects have 24 years of professional experience, with a single engagement typically lasting around 1.9 years.
The most common languages among freelancers in Germany who have used IEC 62304 in their recent projects are German (100%), English (96%), and French (19%).
The most common industries among freelancers in Germany who have used IEC 62304 in their recent projects are Healthcare (93%), Information Technology (81%), and Manufacturing (81%).
The most common business areas among freelancers in Germany who have used IEC 62304 in their recent projects are Information Technology (93%), Quality Assurance (93%), and Product Development (85%).
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.
Berlin Hamburg Munich Cologne Frankfurt Stuttgart Dusseldorf Leipzig Dortmund Essen Bremen Dresden Hanover Nuremberg Request a free demo
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