Partner: Inmarsys
Inmarsys
United Kingdom
Silver
Overview
Inmarsys Limited might be seen as a relative newcomer to the world of Medical device development; however, we have a proven track record and valuable hands-on experience of more than 20 years in Safety-Critical software development industries such as Medical, Aerospace and Automotive. Using this extensive knowledge, Inmarsys Limited can apply it to new and existing Medical device development programs and drive the software in these programs to successful certifications (CE and FDA 510(k)/de Novo).
We offer a complete IEC62304-compliant SDLC creation, SDLC integration with ISO13485 QMS processes, assistance in ISO14971 Risk Management, product Architecture design and Embedded software implementation for Medical devices (MDs) and In-Vitro Diagnostics devices (IVDs). While our primary focus is in assisting Medical Start-ups, we can also offer help to more established organisations and adapt our solutions to their needs.
Contact Information
| POC | Vladmir Plotkin |
| vladimir@inmarsys.com |
Certifications
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