Complete solutions from a single source.
As an experienced development service provider for medical engineering, we offer you a wide range of services, from evaluating your product idea to developing a market-ready product. With our in-depth expertise, we implement your projects efficiently and in compliance with standards – both as complete solutions and in the form of individual trades such as software, electronics or mechanical systems.
Development takes place in our own process, which is certified according to ISO 13485, or in the customer's process. We work on projects in the area of medical devices, ranging from small portable devices to complex systems such as medical robots and implants. These devices also meet the highest requirements, such as risk class III (MDR), software safety class C (IEC 62304) and cybersecurity requirements of level SL 3 (IEC 62443).
In addition, we offer comprehensive advice in regard to risk management, standards-compliant documentation and user-friendly design. Our goal is not only to deliver hardware and software on time, but also ensure that all requirements for a smooth approval in Europe and the United States are met.
With our expertise in managing complex development projects and consistently implementing security requirements through targeted cybersecurity measures, we create solutions that offer maximum efficiency and security. On request, we transfer our in-depth knowledge and our proven, standards-compliant processes directly to our customers to ensure sustainable success and maximum efficiency.
Development services.
We offer comprehensive development services for medical devices ready for approval. Our expertise covers the entire product development process – from conception to the provision of the necessary approval documents. We support you in integrating your solutions into the Internet of Medical Things (IoMT).
Concept
- Performance of feasibility analyses to assess the viability of your project
- Creation of technical product concepts and visualisation of system solutions and individual components
- Advice on technology selection and advice on the approval and conformity assessment of medical devices (placing on the market)
Development
- Comprehensive consideration of the requirements on hardware, software and mechanical systems through system engineering
- Creation of functional, non-functional and qualitative product requirements based on use cases
- Software development for embedded Linux systems, real-time operating systems (RTOS) or bare-metal solutions, as well as medical apps
- Refactoring of software to improve performance or further develop existing systems
- Electronic records of device-specific processes such as logging sensor data or user-dependent GUI entries in accordance with 21 CFR 11
- Development of interfaces for connection to hospital information systems (HIS) (HL7, GDT)
- Development of visualisations and human-machine interfaces (HMI) with a strong focus on usability and user-friendliness
- Development of software with security class up to C
- Hardware development in accordance with the requirements of EN 60601-1
- Enclosure development with hygienic design and protection classes up to IP69K
- Safeguarding of functional safety (first-time error prevention)
- Development of laboratory equipment and production facilities in accordance with GAMP®5
- Process-compliant implementation of tailor-made solutions for cybersecurity, particularly taking into account the combination of safety and security
- Competent management of IT risks, trained in accordance with ISO 31000
- Automated verification and validation by our specialised department
- Provision of documentation for approval in European and American target markets
- EMC and ESD testing during development
- Creation of secure source code and performance of security-related tests in accordance with EN 50128 and IEC 62443
With our expertise, we support you in all phases of development to ensure that your medical device meets the highest standards and complies with all regulatory requirements.
Series transfer and follow-up support
- Support with the approval of medical devices (CE, UL and FDA), as well as recertification, for example, in case of component changes
- Our Product Security Incident Response Team (PSIRT) provides support as part of product maintenance or, upon request, coordinates all activities to ensure cybersecurity throughout the entire product life cycle.
- Support within the scope of product life cycle management (PLC), for example, in case of component discontinuations or product changes
- L2 and L3 support
- Support of the PSIRT team in product maintenance
Cybersecurity for medical products
As a leading development service provider in product security and functional safety, embeX combines expertise from both areas to ensure safety through security. The normative security extensions of the well-known safety-oriented standards are implemented.
The development of safe and secure products creates synergies, as both areas place high demands on the care taken in development and the predictable behaviour of the products. On the other hand, it is necessary to weigh up the balance between a multitude of conflicting objectives of the two security concepts on a project-specific basis, which are shown in a table.
ISO 14971, MDCG 2019-16 and AAMI TIR 57 describe that safety and security risk analyses are fundamentally linked. The challenge in development is therefore to select risk-minimising measures in both areas in such a way that they do not interfere with each other.
Secure software must be developed using secure coding, which must be verified in penetration tests.
After development, product support throughout the product lifecycle is provided by the Product Security Incident Response Teams (PSIRT) pursuant to IEC 81001-5-1. The EU is currently planning to harmonise IEC 81001-5-1 with the MDR by the target date of 24 May 2024, as reported by the Johner Institute.
Guidelines & standards.
We are certified to EN ISO 13485 and work in accordance with the following guidelines and standards, among others:
- Medizinprodukteverordnung MDR (EU) 2017/745
- FDA 21 CFR Parts 11 und 820
- IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60601-2 Particular requirements for the basic safety and essential performance of medical electrical equipment
- IEC 62366-1 Medical devices — Application of usability engineering to medical devices
- IEC 62304 Medical device software — Software life cycle processes
- ISO 14971 Medical devices — Application of risk management to medical devices
- MDCG 2019-16 Guidance on Cybersecurity for medical devices
- IEC 81001-5-1 Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product lifecycle
- IEC 62443 Security for industrial automation and control systems
- IEC TR 60601-4-5 Medical electrical equipment — Safety-related technical security specifications
- Richtlinien der FDA
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
- Postmarket Management of Cybersecurity in Medical Devices
- Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act (Draft)
- AAMI TIR 57 Principles for medical device security
- IEEE 11073 Service-oriented Device Connectivity (SDC) — Participants in a Service-oriented Device Connectivity (SDC) system
Communication
We have mastered the seamless integration of state-of-the-art communication standards. With our expertise, we ensure that your products are always optimally networked - be it for communication between devices, for connection to networks or for integration into the IoTM:
- Bluetooth, USB, Ethernet, WLAN, CAN, MQTT
- IEEE 11073 "Service-oriented Device Connectivity" (SDC)
- HL7 -GDT (device data transfer)
Developed products.
We develop both diagnostic and therapeutic medical products for our customers for a wide range of medical technology applications. You will find us wherever electronics are involved: In operating theatres, intensive care units, hospitals, doctors' surgeries and the homecare sector. In infusion and medication pumps, gateways, medical robots, operating tables, operating lamps, endoscopy systems, X-ray equipment and wheelchairs. In small, mobile devices or large appliances.
You will find our technologies in use wherever the highest standards of functionality, safety and reliability are required in the field of medical engineering:
Further information.
- MEDengineering: Efficient separation of security-relevant and non-security-relevant functions
- www.devicemed.de: Cybersecurity as a customised suit - practical experience in the development of networked devices
- MEDengineering: Alternatives for dual-channel security architectures
- www.devicemed.de: Functional safety for medical devices
