Development of safe medical devices

There are special requirements on medical devices in terms of safety and usability. With mobile healthcare, telemedicine and the networking in the IoMT (Internet of Medical Things), the relevance of information security is increasing. The regulatory requirements for engineering are correspondingly high and are constantly growing, e.g. in the form of the new EU Medical Device Regulation (MDR for short).

What’s more, ever shorter innovation cycles force manufacturers to reduce their time to market. NewTec helps you to overcome these challenges. With technology consulting, engineering services, software solutions and hardware solutions, we have been a competent partner for well-known producers of medical devices for many years.

Electronics and software development of medical technology

NewTec provides comprehensive support in the development of medical devices with worldwide approval up to class 2b and in the development of medical apps. Experienced engineers are at your side for the entire development and product lifecycle – from technology consulting, system and requirements engineering, software and hardware development through to the design of intuitive and safe interfaces.

Safety for medical technology

As specialists in functional safety, we use our expertise, sustainable safety concepts and special hardware and software to ensure that your medical devices meet all the requirements of safety-related standards such as DIN EN ISO 14971, DIN EN 60601 or IEC 62304. From technology consultancy and requirements for implementation through to verification and validation, we ensure certified and proven processes for the safety of your products. To achieve the greatest possible levels of safety and reproducibility, each individual step in the project phase is documented in full.

Security in medical technology

Mobile Health and the Internet of Medical Things place high demands on the information security of networked medical devices (data protection and protection against attacks). There are corresponding regulatory requirements for security, not least because of the MDR and FDA. However, security engineering is uncharted territory for many manufacturers of medical devices.

NewTec supports manufacturers in the development of new medical devices with security analyses and security engineering, including all normative requirements like IEC 60601-4-5, IEC 62443 or ISO/IEC 27001. We’ll advise you on protection against sabotage attacks and external manipulation and check whether and how legacy products can be made fit for the security requirements of networked devices. And we develop safe, data protection-compliant applications.

 

Usability of medical devices

Errors in the operation of medical devices can endanger patients and the users. Simple, safe and intuitive operation is absolutely essential to avoid errors – especially in stress situations.

NewTec provides comprehensive usability engineering, taking into account relevant standards such as DIN EN 62366 and DIN EN 60601-1-6. We determine the needs of the users depending on the situation in detailed application analyses. Based on these analyses, we develop intuitive user interfaces that minimise susceptibility to operating errors as much as possible. To ensure safe operation, even in a wide variety of countries with their own specific requirements, NewTec carries out usability studies taking linguistic and cultural features into account.

Platforms and solutions for medical applications

With our customised solutions and platforms for different areas, we succeed in implementing your medical technology projects quickly and safely.