Sunbird Medical Devices
Sunbird Medical Devices is a medical device consultancy specializing in software development, regulatory compliance, risk management, and quality assurance for medical devices. They provide training, consulting, and fully compliant software development services to help medical device manufacturers meet rigorous safety and effectiveness standards. Their mission is to lower the learning curve for medical device development, increase software engineering team efficiency, and accelerate market submissions, all while ensuring regulatory compliance and patient safety.
Industries
Nr. of Employees
small (1-50)
Sunbird Medical Devices
Brussels, Brussels Hoofdstedelijk Gewest, Belgium, Europe
Services
Compliance consulting for software medical devices, covering standards and regulations, SOP customization, documentation templates and support for certification or market entry.
Workshops and instructor‑led trainings on IEC 62304, IEC 62366, ISO 13485, ISO 14971, FDA cybersecurity guidance and other topics for roles across software, regulatory and product teams.
Contract software development, UX design, verification testing and DevOps services executed in compliance with IEC 62304 and integrated with client QMS/eQMS.
Compliance consulting for software medical devices, covering standards and regulations, SOP customization, documentation templates and support for certification or market entry.
Workshops and instructor‑led trainings on IEC 62304, IEC 62366, ISO 13485, ISO 14971, FDA cybersecurity guidance and other topics for roles across software, regulatory and product teams.
Contract software development, UX design, verification testing and DevOps services executed in compliance with IEC 62304 and integrated with client QMS/eQMS.
Expertise Areas
- Medical device software development
- Regulatory compliance for medical device software (IEC 62304, EU MDR, FDA 21 CFR)
- Usability engineering and UX for medical devices
- Cybersecurity for medical devices
Key Technologies
- IEC 62304 (medical device software lifecycle)
- IEC 62366 (usability engineering)
- ISO 13485 (quality management for medical devices)
- ISO 14971 (medical device risk management)
News & Updates
An article discussing what reliability means in medical devices, emphasizing that trust is not the same as reliability, which is about devices doing what they are supposed to do.
An article explaining the regulations around external software components in medical device software, focusing on IEC 62304 and FDA guidance.
An article analyzing the risk-averse and safety-oriented nature of current regulations around external software components.
An article emphasizing the importance of risk management in healthcare and medical devices, covering principles like risk assessment, control, traceability, post-market surveillance, and regulatory compliance.
An article explaining the regulations around external software components in medical device software, focusing on IEC 62304 and FDA guidance.
An article analyzing the risk-averse and safety-oriented nature of current regulations around external software components.
An article discussing what reliability means in medical devices, emphasizing that trust is not the same as reliability, which is about devices doing what they are supposed to do.
An article explaining the regulations around external software components in medical device software, focusing on IEC 62304 and FDA guidance.
An article analyzing the risk-averse and safety-oriented nature of current regulations around external software components.
An article emphasizing the importance of risk management in healthcare and medical devices, covering principles like risk assessment, control, traceability, post-market surveillance, and regulatory compliance.
An article explaining the regulations around external software components in medical device software, focusing on IEC 62304 and FDA guidance.
An article analyzing the risk-averse and safety-oriented nature of current regulations around external software components.