About
We are a network of senior independent consultants. Heavily experienced in MedTech, we assist you in a task or entire projects, covering all aspects of medical device development.
Our expertise lies in helping you deliver high-quality results saving a number of loops before hitting right. With deep industry knowledge, we provide tailored solutions for your specific needs. We have experts in:
Services
Software as a Medical Device
We help you in your development of a software as a medical device according to IEC62304or IEC82304: Scrum mastering, technical documentation, development of both embedded software and apps.
Combination products and Mechanical Design
We are experts in Design for injection molding, Design of mechanical test methods, Geometry assurance, Supplier Quality Assurance for plastic parts and electronics, material choice in plastic materials.
Security for Medical Devices
We create and deploy cybersecurity processes, help you implement cybersecurity in your medical device.
AI as a medical device
We add models to your medical device. We create them and document them.
Hardware design
We design your PCBA and help you choose components. We can even provide you with prototype boards.
Advisory services & technical documentation
We mentor you in your startup journey
We structure your documentation and tell your team what to write in order to comply with the medical device standards and guidances.
Why work with us
Our team comprises highly skilled and experienced professionals in the field of medical devices, ensuring top-notch service quality and innovative solutions.
We utilize the latest regulatory discussions within AI and cybersecurity. We can execute the cybersecurity part of your projects.
At Promedee, we prioritize personalized care by tailoring our services to meet your specific requirements, providing a unique experience that caters to your individual needs.
We are here to help with any questions or concerns. Contact us for prompt assistance.
