Technology is at the heart of how we look after people.
Our experience across a wide range of safety-critical domains means we put quality and safety at the heart of everything we do. Solutions design, software development, verification and validation activities and deployment – whatever the task, we apply the strictest standards throughout the entire development lifecycle as set by bodies such as the FDA and the European Commission (EC).
Standards like the MDR, the IEC 62304, ISO 13485, ISO 14971, IEC 62366, IEC 60601 series, the 21 CFR Subchapter H, among many others inform every step we take in making medical devices safe.
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, implementation and testing and finishing with certification support.
Cyber Security
Our approach to tackling the cyber security challenges facing the healthcare industry is two-pronged, focusing on supporting both the security of medical devices and systems, and the security of information.
Verification & Validation
Our 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.
Risk Management & Regulatory Affairs
We apply our experience with safety-critical applications to help our clients meet industry requirements in a cost-efficient way.
Brands that trust us
Ana
Rita
Ana Rita (who prefers to be called Rita) has been our Business Development Manager for the Medical Devices and Lifesciences European market since the beginning. She manages all customer relationships in this sector, including potential new clients and partners. On a personal note, Rita loves attending concerts and movies, traveling as often as she can with family or friends, and is a passionate advocate for animal welfare.
Philipp
Rößler
Philipp is responsible for business development in the MedTech and Rail sectors in the North American market. His role involves expanding Critical’s presence and forging strategic partnerships with key clients. When Philipp isn’t working with medical devices or trains, he enjoys practicing haidong gumdo, playing chess, and, of course, football! He has coached youth football teams for over ten years, during which time he introduced all three of his sons to the beautiful game.
Sérgio
Pereira
Sérgio is a Principal Engineer with extensive experience in the medical devices and life sciences industries. He has a proven track record of developing and managing diverse projects while collaborating with multidisciplinary teams. At Critical, he leads the technical aspects of medical device projects, ensuring seamless integration and precise definition of software and hardware specifications. In his spare time, Sérgio enjoys cycling and music.
