Developing and certification of medical software
This includes:
- Creating and maintaining technical documentation
- Software validation in accordance with ISO 62304
- Comprehensive risk management in accordance with ISO 14971
Prosmap - The Medical Product Platform
Prosmap is a SaaS solution developed by biobedded systems GmbH specifically for medical technology. It supports manufacturers in developing medical software and the associated hardware integration efficiently and in compliance with regulations.
The advantages of Prosmap are:
- Centralized management and documentation: With automated audit trails and evidence management for regulatory audits
- Device-independent operation: The user interface runs separately from the hardware and can be used flexibly via smartphone, tablet, or computer
- Easy integration via API: Fast and secure connection to existing systems, e.g., hospital or practice software
- Data security through clear separation: Device and personal data are stored strictly separately and only released in a controlled manner – a decisive advantage for telemedicine and remote care.
- Seamless hardware connection: Support for common interfaces (e.g., audio, USB, Wi-Fi, Bluetooth) for direct connection of apps to medical devices
Seamless connection between app and device
Prosmap enables efficient and secure integration of software and medical devices, both wired and wireless. This allows manufacturers to quickly validate their apps, meet regulatory requirements, and flexibly integrate hardware at the same time. The platform supports common interfaces, offering maximum flexibility in device connectivity:
- Audio via headphone jack: cost-effective, widely used solution with short development time; galvanically isolated
- Serial/USB: robust and inexpensive hardware option for simple applications
- WLAN: fast data transfer, secure login, and high response times – even for battery-powered devices
- Bluetooth: wireless connection, widely used and cost-effective
- Bluetooth Low Energy (BLE): optimized for wearables, energy-efficient and available as a single-chip solution with low system costs
Advantage for manufacturers: With Prosmap, even complex applications can be implemented quickly, efficiently, and in compliance with MDR without compromising user-friendliness or device safety.
Prosmap – A success story
The development and certification of medical apps requires in-depth technical and regulatory knowledge, from software validation in accordance with ISO 62304 and risk management in accordance with ISO 14971 to MDR-compliant technical documentation.
With the support of WQS Management Consultants, biobedded systems GmbH was able to develop Prosmap, a solution that addresses the key challenges in medical technology. The Medical Product Platform combines all relevant steps, from software development to hardware and interface integration to MDR-compliant documentation. Manufacturers benefit from an efficient process that brings secure, user-friendly, and regulatory-compliant apps to market quickly and reliably.
Further information on Software Validation for Medical Apps and Software.
Learn more about the Medical Product Platform: prosmap.de
