***** PREMIUM

Critical Software GmbH

Service Provider

Products

Critical Software GmbHVerification and validation of software in medical devices / products

Our experience in a variety of safety-critical areas enables us to deliver an effective and efficient V&V for increasingly complex and competitive medical technology projects.

From defining verification and validation plans that meet the requirements of the quality system, to testing procedures that must be implemented based on industry standards.

Our comprehensive range of V&V services for medical technology includes:

verification

An activity that encompasses the entire system and software. A verification plan provides reassurance that the design process is well thought out, is performing as expected, and that the product is meeting the needs of stakeholders. The main objectives are:

Selection of verification strategies and techniques.
Choosing the most suitable software test equipment.
Detailed documentation of verification activities.
Evaluation of verification results.
Monitoring of the risk control requirements.
Identifying and maintaining the roles and responsibilities of those involved in the verification and testing processes.

Validation

Cost and time efficient testing capabilities for both software and electrical components of medical devices, in compliance with standards such as IEC 60601 and IEC 62304. Our approach includes a comprehensive set of tests and methods designed to increase effectiveness and reduce time costs including test automation, fault injection, robustness testing, regression testing, hardware and software-in-the-loop testing, system testing, unit testing, and more:

Software tests: component and integration tests in full compliance with the provisions of IEC 62304. Traceability from system requirements to software requirements, hazards, design and verification.
HMI testing: testing of human-machine interfaces such as software applications that run on devices used by doctors.
System test: Definition of test cases for various device functions and execution of test procedures.
Hardware-in-the-loop testing: Support of hardware-in-the-loop simulations of dynamic processes.
Test automation: Use of our tailor-made System Validation Facility (SVF), which can be easily adapted depending on the project requirements and enables a fast response time to test automation activities. The SVF supports the fully automated execution of test scripts and carries out automated tests in order to create comprehensive test campaigns.

More information

Critical Software GmbHAll showrooms

Verification and validation of software in medical devices / product...

Our experience in a variety of safety-critical areas enables us to deliver an effective and efficient V&V for increasingly complex and competitive medical technology projects. From defining ver...

Checking the health of medical devices

A staggering one in three medical devices have suffered recalls because of failures – with software being the most significant factor. We work to make sure this doesn’t happen, ensuring sa...

Development of Medical Devices - Systems and Software Engineering

Software Development We work in each phase of the medical devices’ development lifecycle and deliver turnkey solutions moving up from requirements definition, through to design, implementatio...

Risk Management & Regulatory Affairs

Risk Management & Regulatory Affairs Regulations standardise the rules for manufacturers and is the main way to reassure healthcare providers and patients that the devices they are using are tr...

Cyber security for medical devices and medical technology companies

Cyber Security The security of embedded devices is a pressing concern for society. Medical devices are no different from other computer systems when it comes to their vulnerability to security b...