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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.

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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.

Our approach & roadmap 

By integrating regulated medical device development and validation frameworks with our proprietary roadmap, we embed user-centered innovation and creativity throughout the entire development process.

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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.

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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.

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NEUROCHASE

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DXCOVER

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CLEAR SURGICAL 

PULSEMEDICA

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1NHALER

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ENTEROBIOTIX

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JFD

CAREERS

We’re always looking for innovative talent to join our team. See all positions and submit your CV.

SENIOR DESIGN ENGINEER

Glasgow, UK

Are you an innovative and client-driven product design engineer wanting to work in the med tech industry? If the answer is yes, then we have the right opportunity for you!
 

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