We drive safety in medical devices by helping our clients meet industry requirements in a cost-efficient way.
Critical Software provides certification support and performs safety validation, verification and validation (V&V) and risk analysis.
We also operate in the development and integration of safety-critical electrical medical devices.
We offer our services in full compliance with the highest quality standards such as the International Organisation for Standardisation (ISO) 13485 and 14971, as well as the International Electrotechnical Commission (IEC) 62304 and 82304-1.
A full spectrum of safety-critical V&V services
Our experience in a wide range of safety-critical domains allows us to deliver an effective and efficient V&V solution for increasingly complex and competitive medical device projects.
Our V&V service portfolio for the medical devices industry includes software, component and integration testing to ensure compliance with IEC 62304, as well as the testing of human-machine interfaces such as healthcare software apps.
Furthermore, we carry out system testing that defines test cases for various device functions and executes test procedures; hardware-in-the-loop (HIL) testing, including support for simulations of dynamic processes; and test automation, supporting the fully automated execution and checks of test scripts and medical devices.
Cost-effective RAMS and certification support
We ensure clients adhere to the relevant applicable medical device standards, an integral part of the reliability, availability, maintainability and safety (RAMS) and certification support service.
Our services include project gap analysis, by helping to identify and overcome gaps in safety requirements while considering specific client and project needs.
We also manage functional safety across the medical development process and carry out independent safety assessments (ISAs), which compile and review all project safety articles to assess compliance with the applicable regulation.
Addressing cybersecurity in the medical devices sector
Embedded systems are entering the medical devices industry in full force and their impact is highly unpredictable.
We address cybersecurity challenges in this sector with an approach that focuses on supporting the security of medical devices, as well as systems and information security.
Embedded software development for medical devices
We support medical devices manufacturers in the development, testing and certification of systems based on IEC 62304, covering up to the highest Software Safety Class: C.
Our expertise enables us to produce safety-critical applications, board support packages or components for real-time operating systems (RTOS) compliant with IEC 62304.
We are also experts in the area of refurbishing and evolving medical legacy system using our experience in gap analysis, reverse engineering, re-engineering and re-design of obsolete systems.
Our vast experience across a wide range of safety-critical domains allows us to deliver an effective and efficient V&V solution for increasingly complex and competitive medical device projects.
Our embedded software development experience includes the production of requirements, architecture, design and coding, as well as Verification and Validation activities as a whole.
The security of embedded devices is a pressing concern for society. The rate of new, connected and embedded systems entering the medical devices industry is now so rapid that their impact is unpredictable.
With the entry into force of the Medical Device Regulation (EU 2017/745 MDR) on 26 May 2021, several medical device manufacturers have been updating their post-market surveillance (PMS) processes in their Quality Management System (QMS) in order to comply with the new requirements.
At a system level, the typical development cycle starts at the system concept and finishes at the certification stage, passing through stages such as requirements specification, system realisation and system validation.
The art and science of user experience design (UxD) shapes many of the products and services that surround our day-to-day lives. From online shopping to TV displays, we engage with user experiences every day.
Doctors and other health professionals expect medical devices to assist them more and more during diagnosis and treatment.
Hearing about new medical devices technology that doesn’t include software in one way or another is becoming less and less common.
It is becoming increasingly familiar to hear about medical devices connected to the internet, hospital networks and even other medical devices to improve healthcare and help healthcare providers treat patients.
The United Kingdom left the European Union in January, entering a transition period lasting until the end of the year.
The medical devices industry is brimming with new trends, from 4D printing technology to virtual reality.
The new Medical Devices Regulation (MDR) was set to be implemented last month. However, the current Covid-19 pandemic changed plans for all, including those of the medical devices industry.
Despite delays, medical devices soon cannot be placed on the European market without adhering to a set of new, more stringent safety requirements: the Medical Devices Regulation (MDR).