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IEC 62304 Experts in Germany

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Hire experts who can plan the software lifecycle, prepare compliant development documentation, and support verification, maintenance, and risk control for medical software. Work with specialists who understand IEC 62304 and match you fast with vetted, available freelancers.

Meet FRATCH Experts in Germany, who have recently used IEC 62304

Verified expert

Faruk Sadriu

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Software Developer

Heppenheim (Bergstraße)
Faruk Sadriu

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
Verified expert

Denys Zakhliebaiev

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Technical Writer

Augsburg
Denys Zakhliebaiev

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
Verified expert

Kai Wolf

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Freelance C++/Embedded Consultant — Computer Vision, Embedded ML & Build Systems

Wiesbaden
Kai Wolf

Last position:

Schwarz IT KG

  • Migration of the software development process of a medical technology software to C/C++ package manager Conan and development of macOS-specific system components
Verified expert

Unnikuttan Velamkudy Vijayan

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Managing Director (Co-Founder)

Berlin
Unnikuttan Velamkudy Vijayan

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
Verified expert

Oleksii Kvasnikov

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Software developer (freelance)

Rottenburg
Oleksii Kvasnikov

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
Verified expert

Thomas Arends

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Interim Assignment

Wernau (Neckar)
Thomas Arends

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
Verified expert

Cesar Schneider

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Lead Cloud Engineer

Moosburg an der Isar
Cesar Schneider

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
Verified expert

Monika Weber

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Quality Specialist

Gifhorn
Monika Weber

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
Verified expert

Ould Aly Isselmou

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Functional Safety Assessor

München
Ould Aly Isselmou

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
Verified expert

Elena Chis

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Plant Quality Manager

Bonn
Elena Chis

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
Verified expert

Norbert Linz

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Team Lead Technical Documentation

Eckental
Norbert Linz

Last position:

Team Lead Technical Documentation at ITZBund

  • Creating manuals and guides
  • Advising authors regarding the federal cloud portal
  • Researching and learning new functions
  • Revising technical texts in the Drupal CMS
  • Reviewing technical texts in the Drupal CMS
  • Revising technical texts in Confluence
  • Reviewing technical texts in Confluence
  • BPMN process creation
  • Implementing corporate design/identity guidelines
  • Administration of SharePoint and SIB box
  • Filing technical documents on different drives (SharePoint, SIB box, BSCW)
  • Professional coordination of team members
Verified expert

Jürgen Hertweck

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iOS App Development (AI-based)

Ottobrunn
Jürgen Hertweck

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
Verified expert

Maher Khoury

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Executive Management, Managing Partner

Heddesheim
Maher Khoury

Last position:

Executive Management, Managing Partner 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 e-health and medical technology
  • Freelance work as project manager in various industries, including IT and medical technology
  • Launching innovative products and solutions in medical technology, connectivity, and fitness in international markets
  • Building platforms for e-health and corporate health management
  • Implementing and migrating 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 handling of critical projects
  • Managing IT infrastructure, including server landscapes and SAN systems
  • Advising international company founders
Verified expert

Michael Dassisti

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Consultant Software Architect

Fürth
Michael Dassisti

Last position:

Consultant Software Architect at Railway Systems Company

  • Model based UML software design for safety critical level SIL-4 interlocking rail traffic system, according to CENELEC 50128 and IEC 62279 standards.
  • Skills: CENELEC 50128, IEC 62279, UML Rhapsody code generation, IBM Engineering Workflow Management (EWM), DNG RM requirements tool, Design Patterns, software functional safety, Risk Control Measures, SCRUM.

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

83%

Master's degree or higher

54%

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 30 Aug 2026.

Daily rate distribution

0 2 4 6 8
<€640 €640-​800 €800-​960 €960-​1120 €1120+

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.

1000
750
500
250
Rate comparison chart
Daily rate avg. 843 €

The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.

1000
750
500
250
Rate comparison chart
Median rate 800 €

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 30 Aug 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.

About the technology

What it covers

IEC 62304 defines the software lifecycle for medical device software. It guides how teams plan, develop, test, release, and maintain software that is part of a medical device or used as a medical device. Companies use it to keep software work traceable, controlled, and ready for audits.

Typical work

  • Lifecycle planning and documentation
  • Software safety classification and scope
  • Verification and maintenance records
  • Change control and defect handling
  • Support for audit-ready files

Where it fits

IEC 62304 often sits beside ISO 13485, ISO 14971, and cybersecurity work. It matters for embedded medical software, SaMD, connected devices, and digital health products that need structured evidence. Strong professionals know how to connect software tasks with quality and risk processes.

Why bring in freelancers

Companies usually need outside specialists when they must clean up missing documentation, prepare for a review, or restart a delayed project. Freelance support also helps when an internal team builds the product but lacks direct IEC 62304 practice. In Germany, this is common for medtech firms that need flexible support in English or German.

What strong experts do

Good specialists do more than fill templates. They understand the intent behind the standard and can write practical work products that match real development flow, not just compliance checklists. They should be able to explain trade-offs, support teams during reviews, and keep software evidence consistent.

What to look for

  • Clear traceability from requirements to tests
  • Familiarity with medical device quality systems
  • Experience with risk and change management
  • Ability to work with developers, quality, and regulatory teams
  • Calm, precise documentation habits
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Frequently asked questions

Questions about IEC 62304? Start with the answers below.

IEC 62304 is used to structure the software lifecycle for medical device software and software as a medical device. It helps teams plan development, control changes, verify behavior, and keep evidence that supports quality and safety. Companies use it when the software needs to stand up to regulatory and audit review.

IEC 62304 focuses on the software lifecycle, while ISO 14971 focuses on risk management and ISO 13485 on the quality management system. They are often used together, but they do not replace one another. A strong freelancer knows how to align software work with both quality and risk expectations.

IEC 62304 help is often needed when a project has missing documentation, unclear traceability, or a deadline for a regulatory review. Teams also bring in specialists when they move from prototype work to a controlled product process. In Germany, this often happens in medtech teams that need flexible support without slowing development.

A good IEC 62304 specialist should also understand ISO 14971, software verification, change control, and basic regulatory documentation. If the product is connected or cloud-based, cybersecurity awareness matters too. Familiarity with medical device quality systems is a strong sign of practical value.

For a small gap in documentation, a focused IEC 62304 expert may be enough. For a new product or a project under review, you usually need someone who has worked across the full lifecycle and can guide the team through decisions, not just write documents. The more complex the device software, the more important hands-on experience becomes.

Yes, much of IEC 62304 work can be done remotely because it is documentation-heavy and relies on digital collaboration. Remote specialists can review files, improve traceability, and support teams through workshops and reviews. On-site time can still help when teams need fast alignment with lab, product, or quality staff.

Look for practical evidence that the IEC 62304 specialist has produced usable lifecycle documents, not just theoretical knowledge. Ask how they handle traceability, safety classification, and verification evidence in real projects. Good answers are concrete, structured, and connected to the product context.

No, IEC 62304 applies to many kinds of medical software, including embedded systems, standalone software, and cloud-connected products. It becomes relevant whenever software is part of a medical device or itself performs a medical function. That is why it is important for both traditional device makers and digital health teams.

The average hourly rate of freelancers in Germany who have used IEC 62304 in their recent projects is 105 €, which corresponds to a daily rate of about 843 € based on an 8-hour working day.

Of the freelancers in Germany who have used IEC 62304 in their recent projects, 83% hold at least a Bachelor's degree, 54% 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 2 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 (24%).

The most common industries among freelancers in Germany who have used IEC 62304 in their recent projects are Healthcare (92%), Information Technology (76%), and Manufacturing (72%).

The most common business areas among freelancers in Germany who have used IEC 62304 in their recent projects are Information Technology (96%), Quality Assurance (92%), and Product Development (84%).

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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