Health software development and regulatory consulting

We are a medical device consultancy.
We provide expertise on software development for medical devices.

ISO 9001
IEC 62304
EU MDR
FDA CFR
About Sunbird Medical Devices

We provide trainings, consulting and fully compliant software development for medical devices.

  • Lower the learning curve on doing medical device development (more speed means quicker to market)
  • Increase efficiency of your software engineering team and accelerate your market submission
Learn More About Us
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What we offer

We offer consulting services for software medical device software. Our services include comprehensive trainings and workshops and consulting services, as well as software development and UX, setting us apart from the competition.

Training and Workshops

Our team of experienced consultants routinely train customers in subjects like IEC 62304, cybersecurity for medical devices, and usability engineering for medical devices.

WORKSHOPS FOR:
  • Health tech startups
  • Biotech companies
  • Software engineers
  • Regulatory consultants

Consulting

Sunbird Medical Devices helps clients with all aspects of software development, including documentation, setting up a development team, increasing compliance, and optimizing your team’s velocity within the rules.

WORKSHOPS FOR:
  • Health tech startups
  • Biotech companies
  • Software engineers
  • Regulatory consultants

Software Development and UX

We provide software development as a service including documentation writing and seamless integration into your eQMS. We offer development, testing (verification) and DevOps services.

WORKSHOPS FOR:
  • Health tech startups
  • Biotech companies
  • Software engineers
  • Regulatory consultants

Our approach

Our approach to consulting services starts with a quick scan of our clients’ needs, which allows us to identify the areas where they require support. We then create a personalized offer that is tailored to meet their specific needs, ensuring that our services provide maximum value and are aligned with their goals and objectives.

1. Intake Quickscan

Schedule a call with our team for getting an overview of the your specific situation, and how our offer can help you as efficient as possible. This can be a combination of services, from workshops to hands-on consulting, as well as being a partner in the software dev and ux side.

2. Customized offer

Our customised offer, combining compliance consulting, training and workshops, and software development and UX support, provides a comprehensive solution for medical device software looking to navigate the complex regulatory environment and ensure that their products meet the highest standards of safety and effectiveness.

3. Execution of services

We follow up on the process by maintaining open communication with our clients, providing regular progress updates, and ensuring that our services continue to meet their evolving needs and requirements.

Ready to go next level?

  • Get up to speed quickly with required documentation
  • Accelerate your market submission
  • Increase efficiency of your software engineering team
Schedule a call

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

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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.

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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.

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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.

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