Software development for medical devices
We are a medical device consultancy. We provide expertise on software development for medical devices.
Consulting services
- Software development for medical device expertise
- Optimize your development
- Create compliant software development processes
- Health tech startups
- Health tech scale-ups
- Biotech companies
- Health IT organizations
- Hospitals
Our consulting expertise
At our consulting firm, we specialize in providing compliance consulting services for medical device software. With our broad experience in international, EU and US regulations you will be ready to storm the market in no time, in compliance.
PORTFOLIO
Jonathan Schreiber – CEO
Sunbird Medical Devices helped us navigate the 13485 certification process with a focus on the software aspect of our medical device. Their team was professional, responsive and knowledgeable. I recommend their services wholeheartedly.
We helped to increase of development velocity by simplifying our SOP’s, reducing documentation burdens and improving processes.
We helped Replasia start their journey towards a certified SaMD medical device.
OUR EXPERTISE
IEC 62304 - the standard for software development for medical devices
IEC 62304 is a standard that provides a framework for the software development life cycle of medical device software. It outlines the requirements and processes for the development, validation, and maintenance of medical device software.
ISO 13485 – with focus on product design & development
ISO 13485 is a standard that sets out the requirements for a quality management system for medical device manufacturers. The parts of the standard that relate to product design and development cover the planning, design, and validation processes for medical device products, as well as risk management and documentation requirements.
ISO 14971 - risk management for medical devices
ISO 14971 is a standard that provides a framework for risk management throughout the life cycle of a medical device. It outlines the requirements and processes for identifying, analyzing, evaluating, and controlling risks associated with medical device products.
European Union Medical Device Regulation (MDR)
IEC 62304 is a standard that provides a framework for the software development life cycle of medical device software. It outlines the requirements and processes for the development, validation, and maintenance of medical device software.
FDA CFR 21
IEC 62304 is a standard that provides a framework for the software development life cycle of medical device software. It outlines the requirements and processes for the development, validation, and maintenance of medical device software.
Book a call now
Our team of experts is ready to answer your preliminary questions free of charge, to help you find the best fit for your company.
OUR EXPERTISE
Wessel has 25+ years of software development as well as 6 years of medical device development. His clients describe him as 80% software development expert, 20% regulatory expert. He combines both domains and bridges the gap between development and regulatory teams.
Bianca is an expert in strategic communications with 20+ years of professional experience.
Ivo has experience in both IT infrastructure as well as software development, bridging that gap. He’s worked as Operations Manager, Project Manager, and Consultant.
Explore our latest
Navigating the Waters of Risk Management for Medical Devices
April 8, 2026
Risk management in medical devices goes beyond compliance — it’s a continuous process of identifying, controlling, and monitoring risks throughout the product l
The how and the what of external software components (SOUP or OTS software) in medical devices
March 25, 2026
How SOUP and OTS software are defined in medical devices — and why documentation effort increases significantly with higher risk levels.
The pros and cons of current regulations on using external software components in medical device software (SOUP or OTS)
March 25, 2026
Strict medical software regulations are slowing down updates and innovation — especially for widely used open-source components.
Reliability in medical devices
March 24, 2026
What reliability really means in medical devices—and why it goes beyond trust, safety, quality, and regulation. A clear breakdown of how reliable systems are defined and evaluated in practice.