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We create a stable foundation for the development of your medical devices

Increasing complexity, regulatory requirements, and internationally distributed development teams make system development in MedTech more challenging than ever.
Corscience provides the technical expertise and experience to make such systems easier to manage. Together, we design architectures, interfaces, and safety concepts — creating a strong technical and organizational foundation for efficient product development.

Rely on our flexible, customizable solutions to accelerate your medical device development.

How we support your development

New or Enhanced User Interface Concept

A well‑designed user interface increases both safety and usability. We develop user‑centered solutions that prevent misuse and fully meet the usability and MDR requirements.

Scope of Services

  • Identification of user groups, operating environment, and usage contexts
  • Definition of GUI requirements
  • Navigation structure
  • Touchscreen layouts
  • Integration of voice‑interaction concepts
  • Development of display and control elements
  • Integration of regulatory requirements
  • Analysis and documentation (ISO 62366)
  • Creation of usability files
  • Interactive GUI prototypes

Benefits

  • Modern user interface concepts & improved usability
  • Higher user acceptance
  • ISO-62366-compliant documentation

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Let’s talk about your requirements.

Requirements Engineering

Clearly defined requirements bring clarity to the development process.
Together with all stakeholders, we structure what your system must achieve and which technical and regulatory requirements and risks must be considered — enabling efficient and compliant development.

Scope of Services

  • Collecting and structuring user needs, system requirements, and regulatory requirements
  • Defining clear and testable requirements
  • Conducting system‑footprint workshops
  • Building a traceability matrix
  • System Requirements Specification (SRS)
  • Software Requirements Specification (SWR)
  • Hardware Requirements Specification (HRS)
  • Mechanical Requirement Specification (MRS)

Benefits

  • Gaining clarity on the functional scope of your medical device
  • Identifying and mitigating technical challenges early
  • Improving communication and responsibilities across all stakeholders
  • Ensuring functionality, safety, and usability

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Let’s talk about your requirements.

 

Safety & Isolation Diagrams

Safety and isolation diagrams provide transparency regarding electrical protection measures and system boundaries. They are essential for ensuring patient safety (MOPP), operator safety (MOOP), compliance with standards, and clear documentation according to IEC 60601.

Scope of Services

  • Evaluation of all power supplies, protection paths, and potential hazards
  • Determination of primary, secondary, and patient leakage currents in accordance with IEC 60601
  • Representation of isolation barriers, leakage currents, and safety measures
  • Definition of safety measures with risk controls according to ISO 14971
  • Review and release of diagrams

Benefits

  • Improved alignment between development, testing, and regulatory approval
  • Early identification of design risks
  • Compliance with all safety measures required by IEC 60601

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Let’s talk about your requirements.

Selection of Operating System and Controller

Choosing the operating system and controller defines the technical foundation for any medical device. A strategic selection ensures that functionality, performance, and safety requirements are met — while avoiding integration issues later in the development process.

Scope of Services

  • Analysis of system and performance requirements (processing power, memory capacity, energy consumption, interface requirements)
  • Evaluation of operating systems (stability, licensing, support)
  • Selection of suitable controllers or processors (performance, memory, safety, availability)
  • Evaluation of security and update concepts (patch strategy, user permissions, encryption)
  • Assessment of hardware compatibility
  • Coordination with software and hardware architecture (definition of technical interfaces and communication paths)

Benefits

  • Early detection and avoidance of compatibility issues
  • Operating system and controller optimally aligned with each other
  • Well‑documented selection criteria enable well‑founded decisions

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Let’s talk about your requirements.

Cybersecurity Concepts

A robust cybersecurity concept protects medical systems from tampering, data loss, and system failures. These concepts form the foundation for secure software and support the fulfillment of regulatory requirements under MDR and FDA guidance.

Scope of Services

  • Analysis of system landscape and data flows
  • Threat Analysis and Risk Assessment (TARA) in accordance with IEC 81001‑5‑1 or AAMI TIR57
  • Authentication, access control, encryption, and logging mechanisms
  • Update and patch strategies
  • Definition of threat scenarios
  • Preparation for penetration testing

Benefits

  • Increased product security for the medical device and connected systems
  • Demonstration of regulatory compliance (MDR, FDA, IEC 81001-5-1 und ISO 14971)
  • Ensured long‑term maintainability

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Alarm Concepts

A standards‑compliant alarm concept ensures that warnings in medical devices are clear, prioritized, and easy to understand.
It supports safe patient care and fulfills the alarm management and signaling requirements of IEC 60601‑1‑8.

Scope of Services

  • Analysis of clinical use cases and risks
  • Definition of alarm priorities and categories according to IEC 60601‑1‑8
  • Alarm conditions, escalation paths, and user interactions
  • Validation and testing of alarm functions

Benefits

  • Fewer misinterpretations of alarms, improving patient safety
  • Clearly structured alarm messages that simplify device operation
  • Alarm concepts as evidence for risk management and audit processes

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Let’s talk about your requirements.

System Architecture for Complex Medical Devices

A solid system architecture is the backbone of any successful device development. It defines clear structures, interfaces, and responsibilities so that hardware, software, and mechanics work together seamlessly. With a well-thought-out architecture, we create the basis for safe, scalable, and easy-to-maintain products—from ideation to series production.

Scope of services

  • Creation of the architecture design, including definition of functional blocks and interfaces
  • Consideration of safety requirements (functional safety, general safety per IEC 60606-1)
  • Implementation of cybersecurity requirements
  • Ensuring compatibility of all subsystems and disciplines
  • Scalable concepts and modularization (for variant management, product extensions and reusability)
  • Review and optimization of existing architectures

Benefits

  • Solid foundation for reducing technical risks and errors
  • Basis for good risk and cybersecurity management
  • Guaranteed effective further developments thanks to simple integration of new functions and variants
  • Better collaboration between individual disciplines due to clearly defined interfaces
  • Easier path to approval thanks to complete documentation and compliance with standards

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Let’s talk about your requirements.

 

Rapid Prototyping

Early prototypes significantly reduce development risks. By testing mechanical concepts, functions, and designs at an early stage, errors can be avoided, user feedback can be gathered sooner, and overall development time can be greatly reduced.

Scope of Services

  • Selection of suitable prototyping methods and technologies
  • Creation of functional, design, or interface prototypes (physical or virtual)
  • Creation of CAD models optimized for rapid prototyping
  • Development of functional demonstrators to evaluate system behavior and interfaces
  • Execution of tests and evaluations
  • Coordination with risk and usability engineering

Benefits

  • Early visualization and functional testing
  • Clarity regarding technical and conceptual feasibility
  • Early feedback from users and patients
  • Focused testing accelerates development
  • Reliable decision‑making basis for architecture, design, and serial development

Contact

Let’s talk about your requirements.

Our Service Packages for Your Success

Drawing on experience from numerous MedTech projects and close collaboration with leading manufacturers and startups, we offer tailored service packages designed to bring your medical device development to its goal faster, safer, and with confidence.

Let us help improve your processes.

 

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We also support you in related areas

Development projects typically span more than a single discipline. Here you’ll find related solution areas that help move your development forward.