Medical Devices

Fail-safe and robust embedded systems are the essential requirement for competitive medical devices.

b1 Engineering Solutions develops innovative and reliable medical devices for you. To this end, we place our experience from working with leading edge companies in the medical device industry at your disposal. Our expertise includes critical life-support, intensive care systems, patient monitors, devices for emergency medicine and telemedicine, as well as diagnostic and therapeutic systems.

Faster time-to-market for new, innovative products, cost optimization in compliance with medical devices norms and standards and ensuring all quality requirements are on our daily agenda. Of course, b1 Engineering Solutions is ISO 13485:2016 certified and our developers are working according to MDR.

Our core competencies include:

  • Embedded hardware design and development according to IEC 60601
  • Embedded software design and development according to IEC 62304
  • FPGA based solutions: on request also according to IEC 62304
  • Fast and secure communication, wireless and wire bound using various interfaces and protocols
  • Solutions for mobile devices, wireless power transmission & wireless charging
  • Development of GUI/user interfaces of high usability

  • Support in the certification of medical devices (MDG/MDD, MDR, and FDA). We have all the necessary documents and a sophisticated design control process.
  • Functional safety and risk management according to DIN EN ISO 14971 and IEC 61508
  • Documentation, verification/validation and development of automated tests

  • Lifecycle Management

High-tech industrial applications

Robust embedded electronics, safe software and reliable networking of all components or complex systems are the drivers for 90 % of all industrial innovations. Mobile user interfaces, highest performance at massive data rates and complex safety functions open up completely new challenges. b1 Engineering Solutions combines these demanding competencies in a one-stop shop and brings to you competitive advantages for your product.

With over 25 years of experience in the areas of fail-safe electronics and software, high-speed connectivity, functional safety, human-machine interfaces, IoT and M2M devices, and lifecycle services, b1 Engineering Solutions is your innovative development partner at eye level.

Our customers in the industrial environment include leading companies in railway technology, aerospace and defense, monetary systems and industrial automation.

Our solutions:

  • Development of reliable embedded electronics and software

  • FPGA developments on the platforms of Intel/Altera, Xilinx and Lattice

  • Wireless and wired interfaces for data, audio and video

  • Development of mobile devices

  • A proprietary and modular IoT platform as the basis for your future devices

  • Wireless power transmission & wireless charging according to the Qi standard

  • Development of GUI/user interfaces using modern development tools

  • Approval consulting, and validation & verification in the field of functional safety: railway (EN 50128), aviation (DO-178B), industry (IEC 620619)

  • Documentation, verification/validation and development of automated tests

  • Lifecycle management


Development projects for the automotive industry are becoming increasingly complex due to the ever growing number of electronic and software components in vehicles. The change towards constantly networked e-mobility and autonomous driving is raising the hurdle for automotive developments.

b1 Engineering Solutions supports you throughout the entire product development cycle, from product concept and architecture, design, implementation, system integration, verification and testing to lifecycle management and maintenance.

As a partner of leading vehicle manufacturers and suppliers (OEM and Tier 1), we develop individual solutions for ECUs (electronic control units), communication platforms, display and control elements and multimedia applications as well as components for driver assistance systems and vehicle safety.

You too can benefit from our many years of experience in the development of vehicle electronics:

  • Requirements engineering and management

  • Design, development and maintenance

  • Individual solutions for control units and their system integration

  • FPGA controllers for electric motors for electric mobility

  • Solutions for infotainment, multimedia applications and instrumentation

  • Driver assistance systems and autonomous driving

  • Functional safety, ASIL, ISO 26262

  • Components for hybrid and electric cars

  • System architecture

  • Platform development

  • Networking of vehicle and cloud, V2X

  • Location-based services

  • Human-machine interfaces

  • Telematics and telemetry solutions

  • Verification/validation, comprehensive test procedures and automated testing

Embedded Elektronics

b1 Engineering Solutions covers the entire electronics development process for you. We support you from early concept and requirements phase through architecture, design and development to integration testing, including long-term lifecycle management for your complete product portfolio.

With leading-edge technologies and certified process quality, we increase your development efficiency, give you a distinct competitive edge through access to our many years of experience of designing complex systems and, thus, help you to significantly reduce the time-to-market for your innovative products.

We offer you:

  • Development of solutions for safety-critical applications according to ISO 13485:2016, IEC 60601, IEC 61508, ISO 26262, EN 5012x, ISO 13849, etc.

  • Experience with various CPUs and microcontrollers, including models from ST, NXP, Freescale, Texas Instruments, Infineon, Intel, etc.

  • Own ARM STM32 and IoT/modem platform

  • Reliable high-speed electronics up to 40 GHz

  • Wireless and wired communication solutions (LTE, GSM, LPWA, LoRa, NBIOT, WLAN/Wi-Fi, VOIP, NFC, RFID, Bluetooth, ZigBee, Ant+, Ethernet, CAN, etc.)

  • PCB design with Mentor Boardstation/PADS/Xpedition, Altium and Pulsonix up to over 20 layers

  • Power integrity and signal integrity analysis and optimization

  • HW/SW integration and test automation

  • Certified solutions (EMC, CE)

  • Mechanical construction

  • Proven partnerships with leading EMS

Embedded Software

b1 Engineering Solutions covers your entire software development process. From concept and requirements phase, through architecture and development phase, to integration testing and V&V, including lifecycle management for your products.

Using modern development methods and the highest process quality, we increase your efficiency in software development, give you a distinct competitive edge by using proven design patterns and libraries and, thus, help you to significantly reduce the time-to-market for your innovative products.

We offer you:

  • Concept development and requirements engineering for your software projects

  • Embedded, mobile and PC solutions in C, C++ and C#

  • Developments under Embedded Linux, QNX and VxWorks, under Android and iOS on mobile devices and under Linux and Windows on PC environments

  • Firmware and board support package (BSP) developments on various microcontrollers and CPUs

  • HMI/GUI applications with Qt and Squish

  • IoT/M2M/connectivity solutions (LTE, GSM, LPWA, LoRaWan, NBIOT, WLAN/Wi-Fi, Bluetooth, ZigBee, SigFox, Ant+, SIP, TCP/IP, AVB, TSN, Ethernet, CAN, etc.)

  • Safety critical solutions according to ISO 26262, IEC 62304, IEC 61508, EN 5012x, and others

  • Development according to V model, waterfall, Agile/SCRUM, RUP

  • Use of modern tools: GIT, SVN, Jenkins CI, Eclipse, Polarion, Jira, PolySpace, VectorCast, Reqtify, DOORS, ClearCase, Python, PHP, etc.

  • HW/SW integration and test automation

  • Design transfer and training

FPGA Design

We also cover your entire development process in the area of FPGA/VHDL/Verilog. From concept and requirements phase, architecture and development to integration test and design transfer, you can rely on our experience with FPGA developments. Our long-term proven partnerships with Intel, Lattice and Xilinx form the basis for a successful cooperation.

We offer you:

  • Concept and requirements engineering for FPGA solutions

  • Design & implementation, logic synthesis: VHDL, Verilog, state machines

  • Experience on Xilinx (Zynq), Intel/Altera, Lattice, Microsemi
  • IP core development and integration of 3rd party IP cores
  • Test bench development and powerful formal verification technologies
  • Solutions for fast audio and video communication, HDMI, SDI, 4K/8K, 3D, image fusion
  • Algorithms for image processing
  • Data transmission and protocols with lowest latency
  • Coding, data protection, and security concepts
  • System-on-Chip/SoC solutions
  • Benchmarking of competing technologies: FPGA vs. GPU vs. DSP
  • FPGA integration on PCBs
  • Replacement of discontinued CPUs and controllers with FPGAs


Your contacts at b1 Engineering Solutions GmbH & Co. KG:


Our customers include well-known, public corporations as well as start-ups and many medium-sized companies:

3M, Adidas, Ambu, Annax, Asclepion, Beissbarth, Blaupunkt, BMW, Bosch, Brusa, BSH, BTT Health, Carl Zeiss, CI Tech, Dentsply, Deuta, DLR, DornierMedTech, Dräger, EADS, ETAS, Faulhaber, Flex, Fresenius Medical Care, General Electric/GE, Getinge, Giesecke & Devrient, GS Elektromedizinische Geräte, Hensoldt, Hexagon, Hofer, Implen, Invendo, Isar Aerospace, ISAR-M, iThera Medical, Jenoptik, Knorr-Bremse, Lauda, Lear, Leica, LivaNova, Magnosco, Maquet, MBtech, MS Westfalia, Nanotemper, Nokia, NSN, Pulsion, Richard Wolf, Siemens, Simeon, Sirona, SMA, Somatex, SOMNOmedics, Sorin, Stryker, TechniSat, TTTech, Ulrich Medical, Wabtec, ZI Imaging, etc.

Functional Safety

When developing products where faulty behavior can lead to health hazards, device manufacturers and distributors are legally obliged to prove that their products have been developed in compliance with the prescribed safety guidelines, norms and standards.

Whether the development of safety-critical products is already one of your core competencies or whether you plan to do so in the future, b1 Engineering Solutions offers you comprehensive support in the area of functional safety, tailored to your needs:

  • Analysis of safety requirements in accordance with the relevant norms and standards
  • Development of the technical architecture that meets all required security aspects
  • Realization/development of all safety-relevant functionality
  • Coordination during development with TÜV, DEKRA, BSI, LRQA, DNV, DQS, SGS, etc.

We advise and support you in the cost-efficient development of your products in order to meet the required safety standards and accompany you during the acceptance of the safety-relevant functionality.

Our employees are trained in the following norms and standards:

  • IEC 61508 (safety standard)
  • ISO 26262 (systems in motor vehicles)
  • EN 50128 (software for use in railway technology)
  • IEC 62304 (medical device software)
  • IEC 62061 (safety of machinery)
  • DO-178B (avionics Software)

Project Management

Interdisciplinary teams, distributed development locations, complex and at the same time dynamic supply chains combined with a large number of project partners characterize today’s product development projects. This results in the need for efficient and consistent, classic or agile project management.

In product development, developer networks are often very dynamically structured. These structures frequently consist of changing partners, which are distributed worldwide and are multiculturally organized, and which themselves make use of various suppliers.

Professional project management is a decisive factor in ensuring the right quality and a timely market launch of your products. The ability to seamlessly coordinate all project partners and thereby coordinate different development methods and philosophies is a key success factor.

b1 Engineering Solutions provides all necessary project management services to plan projects efficiently and lead them to success in a dynamic environment. We also advise our customers on the introduction of modern project management methods and tools or take on the coordinating role between your project partners so that you can concentrate on your actual core task – product development.

The project managers at b1 Engineering Solutions have many years of extensive experience in project management in a wide range of industries through numerous successfully completed projects. Our project managers are IPMA or PMP certified and have project experience with both the classic V-model and agile project management (SCRUM).

Requirements Engineering

High quality defined requirements form the basis for an optimized project execution under budget, time and quality aspects. Well formulated requirements are the prerequisite for a transparent and comprehensive product development process. The traceability of requirements is a prerequisite for many approval processes.

Technically complex products, a high number of variants, short product life cycles and highly fragmented supply chains require extremely efficient and effective methods to develop and manage requirements in such a way that the overview and control of product functions is guaranteed at all times.

b1 Engineering Solutions supports you in all areas of requirements engineering, from the collection of initial user requirements to requirements analysis, specification and documentation of technical system and component requirements, for example in the form of requirement and functional specifications, and tool-supported requirements management.

Furthermore, we advise you on the introduction and optimization of a streamlined requirements management processes, modern methods and established tools such as Polarion, DOORS and Reqtify.

Configuration Management

The goal of configuration management is the correct, transparent and uniform configuration and management of all artifacts involved in the development process. Configuration management is therefore the central link in all phases of the product development process.

Professional configuration management helps to master the technical complexity of modern products. Target-oriented processes, proven methods and appropriate tool support are necessary prerequisites.

b1 Engineering Solutions offers you consulting and support for selecting, customizing, implementing and operating the configuration management solution that is best for you. We support you in the migration and consolidation of existing solutions and help you to introduce state-of-the-art configuration management methods that suit your needs.

Test Engineering

Systematic test engineering and test management integrated into the overall development process ensure that errors are detected in time and not just immediately before the planned product delivery. The earliest possible error detection reduces subsequent errors and secures your planned budget, dates and milestones.

With the increasing technical complexity of products, especially when products also have to meet safety-critical requirements, the need for systematic testing throughout the entire development process from unit test to integration test, system test and regression test, increases.

b1 Engineering Solutions supports you in all areas of test engineering and test management, from the creation of test concepts and test strategies to test definition and test execution. We are also happy to support you in outsourcing complete test processes. Our strengths also lie in the automation of manual testing activities.

Furthermore, we advise you on the introduction and optimization of test engineering and test management processes, modern test methods and the corresponding tools such as Jira, Squish, PolySpace and VectorCast.

Lifecycle Services

Product managers are faced with enormous challenges in view of the constantly increasing number of product variants, combined with increased product complexity and ever shorter innovation cycles. b1 Engineering Solutions offers you product lifecycle management solutions: we analyze and support your products already placed on the market. We take over the support and further development of these products for you. This allows you to concentrate efficiently on your core business and develop the products of the next generations.

b1 Engineering Solutions has many years of experience in the redesign and end-to-end maintenance of existing products. We offer you:

  • Analysis of new product requirements (change request and impact analysis)
  • Development of alternative design proposals and solutions
  • Implementation of change requests from specification to acceptance
  • Level 2 and level 3 support and bug-fixing services
  • Component management, component replacement and 100 % compatibility assurance
  • Logistics services such as documentation, data management and ensuring configuration integrity
  • Tool chain and process improvements
  • Detailed and transparent status reporting
  • 10 to 15 years product support according to your specifications

In addition to these services, we also analyze possibilities for performance improvement and energy saving. We undertake necessary adjustments to the products we support in order to address changing norms, standards and new legal requirements.

Today, more sophisticated operating concepts and new demands on the networking capability of products are important factors that can have a strong influence on the lifetime of devices established on the market. Through targeted product adaptations we can extend the life cycle of your products and ensure the competitiveness of your portfolio.

Post Market Surveillance

The obligation of all medical device distributors to install a post-market surveillance (PMS) system is clearly defined in the Medical Device Regulation (MDR). A qualified PMS system shall provide means to gather in-depth knowledge on the use of your medical devices and to leverage any potential for improvement. Therefore, in order to remain both compliant and competitive, all vendors of medical devices face the challenge of proactively tracking and verifying the use of their devices in the field.

Our approach is based on a data-driven solution of a proactive PMS system. Data from your entire installed base is automatically collected by real-time sensors and sent securely to a centralized server. Based on the data base collected in this way, it is possible to perform an analysis of the respective equipment condition and, if necessary, to initiate corrective actions (CAPA) using predictive methods. Content for the required PMS reports can be generated automatically, so that you can fulfill your regulatory obligations with as little personnel effort as possible.

Based on the cooperation of b1 Engineering Solutions, FSQ Experts and Clockworkx, we can provide you with comprehensive expertise in the field of PMS: from the necessary embedded electronics and software, to secure data transport, storage and analysis, to MDR-compliant technical documentation, as well as the implementation of a holistic PMS process in your company.

We will provide you with an individual solution for your medical equipment landscape. With our support in technical as well as regulatory issues, you will get an efficient, compliant and secure PMS system.