Secure Development of Medical Technology: Safety, Security & MDR Compliance
Learn how to master the challenges of the MDR and efficiently develop safety-critical medical technology. From safety and security to usability engineering.
Comprehensive Support for Medical Device Development
Special requirements for safety and usability apply to the development of medical devices. With mobile healthcare, telemedicine, and networking in the IoMT (Internet of Medical Things), the relevance of information security (security) is also increasing. In addition, there are growing regulatory requirements such as the EU Medical Device Regulation (MDR).
NewTec GmbH supports manufacturers in mastering these challenges. With technology consulting, engineering services, and software and hardware solutions, the company has been a partner to well-known medical technology manufacturers for many years.
Safety & Security for Medical Technology
As a specialist in functional safety, the team uses profound know-how and sustainable concepts to ensure that medical devices fulfill all safety-relevant standards such as DIN EN ISO 14971, DIN EN 60601, or IEC 62304. Every step is documented without gaps to achieve the greatest possible traceability.
In the area of security, NewTec supports new developments with security analyses and security engineering, taking into account normative requirements such as IEC 60601-4-5, IEC 62443, or ISO/IEC 27001. This includes protection against sabotage attacks as well as data protection-compliant app development.
"In all process stages, the relevant specifications of the FDA as well as the ISO and IEC standards for the development of medical systems must be taken into account."
Usability Engineering
Operating errors can endanger patients. An intuitive user interface is therefore indispensable. NewTec offers comprehensive usability engineering according to DIN EN 62366 and DIN EN 60601-1-6. Through detailed application analyses, the needs of the users are determined and the risk of incorrect operation is minimized.
Platforms for a Faster Time-to-Market
To shorten development time, NewTec offers various platforms and solutions:
- Wireless Solutions: Secure networking of IoMT devices with high transmission reliability and low latency.
- Cloud Platforms: Solutions for secure mobile health apps and patient data management.
- Safety Platforms: Pre-developed hardware and software modules (e.g., based on STM32 or FPGA) significantly reduce development effort.
Practical MDR Support
The implementation of the MDR presents many manufacturers with major hurdles. NewTec supports MDR-compliant development, helps to make legacy products fit for approval, and creates the necessary technical documentation.
Visit us at MedtecLIVE 2026 to learn more about our engineering services and solutions for modern medical technology.
