IEC 62304 Experts in Germany
matched in minutes from over 15,000 CVsHire experts who plan software safety classifications, establish IEC 62304 lifecycle processes and prepare evidence for audits and submissions. FRATCH matches you quickly with vetted, available freelancers who fit your medical device software 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
Roland S.
Last position:
Aerosol Generator Technology – Industrialization Partnerships
Aerosol Generator Technology – Industrialization Partnerships
Engaged by a former technology partner to identify and approach potential partners for further industrialization and commercialization of its vibrating membrane nebulizer aerosol generator technology.
Kai W.
Last position:
Schwarz IT KG
- Migration of the software development process for medical technology software to the C/C++ package manager Conan and development of macOS-specific system components
Kevin P.
Last position:
Industry Software from Route to Invoice
Industry Software from Route to Invoice
In Production
In use at: landscaping company, two home care services
The entire workday, digital: sign-in, route plan on the vehicle, departure checks, photo documentation, time tracking, invoicing. The tablets keep working offline and sync afterward. Records are immutable, making time tracking easier to audit. Runs on a dedicated server in Germany with continuous monitoring and remote updates.
Proof: In daily use at the landscaping company with six vehicles since September 7, 2026.
- React Native on Android tablets
- Python
- SQLite
- Two-way synchronization
- Linux server in Germany
- Remote maintenance
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.
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
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
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
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
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
2 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
85%
Master's degree or higher
59%
Doctorate
7%
Certifications per freelancer
4
Most common languages
German, English, French
Speak two or more languages
100%
Based on our profile pool as of 29 Oct 2026.
Daily rate distribution
The chart shows how the daily rates of experts in this technology in Germany 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 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 29 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.
- Healthcare (93%)
- Information Technology (83%)
- Manufacturing (79%)
- Automotive (52%)
- Energy (34%)
- Telecommunication (28%)
- Transportation (24%)
- Pharmaceutical (24%)
Please note that freelancers can work across multiple industries, so percentages overlap.
About the technology
What IEC 62304 Covers
IEC 62304 is the international standard for medical device software lifecycle processes. It defines how teams plan, develop, verify, maintain and retire software used in or as a medical device. The standard focuses on controlled processes, documented evidence and risk-based activities.
Software Safety Classes
The standard links lifecycle rigor to software safety classification. Specialists help determine whether software falls into class A, B or C by considering the possible impact of hazards, then align controls and evidence with that classification. The result is a defensible basis for planning and review.
Lifecycle Activities
IEC 62304 work spans the full software lifecycle, not only implementation. Typical deliverables include:
- Software development and maintenance plans
- Requirements, architecture and detailed design records
- Verification, integration and release evidence
- Configuration and problem-resolution processes
- Traceability from risks and requirements to tests
Ecosystem and Tooling
Strong professionals connect IEC 62304 with ISO 14971 risk management, IEC 62366 usability engineering and ISO 13485 quality systems. They may work with requirements and test management tools, version control, issue tracking, static analysis and automated verification. In Germany, they often support teams preparing technical documentation for regulated medical products while collaborating with quality and regulatory functions.
When to Bring in Specialists
Companies commonly seek freelance expertise when a product enters a new development phase, an audit exposes gaps or an existing process must scale. Useful signals include:
- Missing links between requirements, risks and tests
- Unclear software safety classification or lifecycle scope
- Legacy software without reliable change records
- A need for independent verification or remediation
What Good Expertise Looks Like
A capable IEC 62304 professional can translate the standard into practical workflows without creating unnecessary documentation. They ask how the software affects patient and user safety, distinguish product evidence from process evidence, and make decisions traceable. For remote work, clear ownership, secure access and disciplined review routines matter; on-site collaboration can help when teams need close process alignment.
Frequently asked questions
Questions about IEC 62304? Start with the answers below.
IEC 62304 is used to define and control the lifecycle of software that is part of, or used in, a medical device. It covers planning, requirements, architecture, implementation, verification, maintenance, risk-related controls and retirement.
IEC 62304 focuses on software lifecycle processes, while ISO 13485 addresses the quality management system and ISO 14971 addresses medical device risk management. A strong specialist connects their outputs so risks, requirements, controls and tests remain traceable.
IEC 62304 is widely used as the lifecycle framework for medical device software, but its exact application depends on the product, intended purpose and applicable regulatory route. Specialists assess the scope and safety classification rather than applying identical documentation to every product.
IEC 62304 work benefits from knowledge of ISO 14971, ISO 13485, usability engineering, cybersecurity and verification methods. Experience with requirements management, configuration control and technical documentation is also valuable.
IEC 62304 expertise should match the product risk, lifecycle stage and state of the existing documentation. A specialist supporting a new safety-critical product needs deeper process and evidence experience than someone helping with a narrowly defined remediation task.
IEC 62304 activities can often be completed remotely when teams provide controlled access to requirements, repositories, risk files and quality records. On-site work in Germany may be useful for process workshops, audit preparation or close coordination with product and quality teams.
IEC 62304 quality is shown through practical evidence: clear lifecycle plans, useful traceability, proportionate documentation and well-structured verification records. Ask how the specialist handled safety classification, changes, unresolved anomalies and links to risk controls on comparable products.
IEC 62304 adds regulated lifecycle controls and objective evidence to ordinary software development practices. It requires defined responsibilities, documented decisions, verification activities, configuration control and maintenance processes that support the product’s safety case.
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 858 € based on an 8-hour working day.
Of the freelancers in Germany who have used IEC 62304 in their recent projects, 85% hold at least a Bachelor's degree, 59% hold at least a Master's degree, and 7% 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 2 years.
The most common languages among freelancers in Germany who have used IEC 62304 in their recent projects are German (100%), English (97%), and French (17%).
The most common industries among freelancers in Germany who have used IEC 62304 in their recent projects are Healthcare (93%), Information Technology (83%), and Manufacturing (79%).
The most common business areas among freelancers in Germany who have used IEC 62304 in their recent projects are Information Technology (93%), Quality Assurance (90%), and Product Development (86%).
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 
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