Medical Device Design and Development Specialists

20+ years of Successful Medical Device Development

Contact us now if you are looking for:-

20+ Years of Medical Device Development

Demonstrable success in bringing medical devices from concept to market
Initial, concept and design, through development and prototyping, to testing, regulatory approval, and scale- up to manufacturing.
Safely navigate of medical regulations, standards, and patient safety requirements
Rapidly prototype and iterate designs based on testing feedback to refine product concepts
Specialists in wearable technology, loT devices, and embedded systems critical to medical applications

Medical Device Design Delivered

From new product development to stalled projects, the Electronics machine is your creative partner in bringing products to market quickly. Decades of experience mean we understand how valuable the ability to innovate is, the need for strong problem-solving skills, the ability to think outside the box, and a willingness to explore novel solutions. We place parallel importance on leveraging the latest technologies and methodologies to overcome design challenges, enhance device functionality, or reduce costs. The Electronics Machine will ensure your new NPD will meet the stringent demands of the medical field.

A remarkable device from The Electronics Machine improved patient care, efficiency, and diagnostic accuracy.

Whether you have a new product development or are reviving a stalled project, our approach can streamline the development process, ensure smoother transitions between phases and reduce the time to market. Our approach also simplifies communication and project management, making it easier to maintain project timelines and budgets.

Take Advantage of Our 20+ Years of Experience Medical Device Development

FREE 30-minute consultation

Application Risk Management

Compliance with ISO 14971 and the application of FMEA within its framework is crucial for the development of electronic medical devices in the UK, primarily for ensuring patient safety and meeting regulatory requirements. Understanding and implementing the requirements of these standards can facilitate smoother regulatory approvals and market access. Additional standards like ISO 13485 and the IEC 60601 series might also apply based on the device’s specific characteristics and intended use.

Electromagnetic Compatability Testing (EMC)

EMC testing, as outlined in BS EN 60601, is a critical component of developing electronic medical products in the UK. It ensures that products are safe, perform reliably in their intended environments, and meet regulatory requirements for market access. By adhering to these standards, manufacturers can mitigate risks, avoid legal and financial repercussions, and build trust with users and stakeholders, ultimately contributing to the successful deployment of medical technologies in healthcare settings.

Approvals, Reliability Trials, Patents & Clinical Trials

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