Critical Software Testing and Software Development for Medical Devices

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.

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Building Cybersecurity from Manufacturer to End-User

Hearing about new medical devices technology that doesn’t include software in one way or another is becoming less and less common.

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Critical Software

Parque Industrial de Taveiro, lote 49

3045-504 Coimbra

Portugal

+351 239 989 100 www.criticalsoftware.com

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Regional Offices

Critical Software

Parque Industrial de Taveiro, lote 49

3045-504 Coimbra

Portugal

+351 239 989 100 www.criticalsoftware.com
UK Office

4 Benham Rd

Chilworth

Southampton

SO16 7QJ

United Kingdom

+44 23 8011 1339 www.criticalsoftware.com
Germany Office

Agnes-Pockels-Bogen 1

80992 München

Germany

+49 618 170 790 13 www.criticalsoftware.com
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