CONSULTANCY
Software development for medical devices
We are a medical device consultancy. We provide expertise on software development for medical devices.
CONSULTANCY
Software development for medical devices
We are a medical device consultancy. We provide expertise on software development for medical devices.
Consulting services
What we offer:
- Software development for medical device expertise
- Optimize your development
- Create compliant software development processes
For who?
- Health tech startups
- Health tech scale-ups
- Biotech companies
- Health IT organizations
- Hospitals
- IEC 62304
- ISO 13485
- ISO 14971
- EU MDR
- FDA CFR 21
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.
Want to discuss what we can do for you?
PORTFOLIO
NEUROVENTIS
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.
BIOGEN
We helped to increase of development velocity by simplifying our SOP’s, reducing documentation burdens and improving processes.
REPLASIA
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.
About our consultants
GILIAM GANZEVLES
Giliam is a designer and UX expert with years of medical device experience. He teaches UX, including IEC 62366, and is also knowledgeable in software development processes. He has planned many workshops in his life so he can give your perfectly educational workshops.
WESSEL KOOYMAN
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 BAUMLER
Bianca is an expert in strategic communications with 20+ years of professional experience.
IVO KOOIJMAN
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.
MAREK SULIGA
Marek is a veteran software expert with experience as Software Architect, Team Lead and of course as a developer.
Explore our latest
Reliability in medical devices
When we are dealing with medical devices, we expect them to be reliable. But what is reliability in these devices? Reliability is not trust When
The how and the what of external software components (SOUP or OTS software) in medical devices
Currently, when developing software for medical devices, there are two sets of rules that deal with external software components: IEC 62304 and the FDA guidance
The pros and cons of current regulations on using external software components in medical device software (SOUP or OTS)
The regulations around external software components are mostly risk-averse and safety oriented. This negates the benefit of updating components frequently. In this article, we look
Navigating the Waters of Risk Management for Medical Devices
Introduction In the realm of healthcare, patient safety is paramount, and this holds especially true for medical devices. The development, manufacturing, and distribution of medical