design for life.
ABOUT US
Redefining Medical Device Innovation Through Human-Centred Design
Fearsome delivers comprehensive design & development services to clients in the medical devices industry, with core competencies in technology development, design engineering, product design, human factors, usability engineering, design transfer, design quality assurance, regulatory compliance and project management.
We can tackle a whole project in a turnkey fashion, or feed into a wider programme where there is a particular need. We are ISO 13485 certified, with regulatory experience across FDA 21 CFR Part 820 and EMA MDR/IVDR frameworks.
Specific areas of expertise include drug delivery and combination products, ophthalmic devices for diagnosis and treatment, surgical instrumentation, wearable and implantable devices.
SERVICES
Expert Services in High-Risk Medical Device Development and Delivery
We specialise in developing high-risk medical devices across a range of fields, with a strong focus on ophthalmology, drug delivery and neurosurgery as well as other key areas. Our expertise spans surgical tools, diagnostic equipment, and cutting-edge technologies, ensuring innovative and compliant solutions tailored to your needs.
Collaboration
Our longstanding collaboration with Greenlight Guru, having utilised their QMS for several years, reflects our unwavering commitment to delivering true quality in medical device development. By prioritising robust regulatory and quality management processes, we ensure that our clients' products meet the highest industry standards, from design through to market delivery.
Skilled Team
As a team, we have experienced project managers, excellent product designers, and mechanical, mechatronic, and biomedical engineers. In collaboration with stakeholders and customers, our diverse team is able to deliver cutting edge medical device projects and provide top drawer solutions.
We continually invest in the growth and development of our team.
WHY FEARSOME
We thrive on complex challenges and are committed to innovating alongside you.
To successfully bring your medical device or development programme to market, we apply agile methodologies tailored to your specific requirements.
We create collaborative frameworks that foster cross-functional teamwork, encourage creative problem-solving, and ensure practical, user-focused thinking throughout the development lifecycle — from early concept to regulatory submission and manufacturing readiness.
Fearsome In Numbers
25+
EMPLOYEES
10+
CORE AREAS
50+
MEDICAL DEVICES
200+
PROJECTS
INDUSTRY
Our
Clients
We have a wide field of experience working with different types of clients in the medical and healthcare industries. We place a high value on our interactions with our clients and frequently discover that we have common ideals and values. A large number of the clients we work with share our commitment to making a positive impact on people's lives through medical device innovation.
NEUROCHASE
DXCOVER
CLEAR SURGICAL
PULSEMEDICA
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ENTEROBIOTIX
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