Medical
MedTech Development
The path from idea through development to clinical acceptance is long and complex. But ultimately the most rewarding of all technological innovation.
We work with many dedicated people who design and develop products with the capability to change someone’s life. From clinicians to surgeons to imaging specialists. It’s a challenging process. One which we know extremely well.
Early engagement with experts gives you the best possible chance to develop a medical technology which is designed from the start with all of the regulatory requirements in mind.
Understanding the complete process enables efficiency in design and development
We Know MedTech
It’s where we started.
When high tech, fast-moving innovation comes face to face with the reality of a highly-regulated risk-averse complex market, experience is valuable.
Designing and developing a medical device requires a risk management approach. Depending on the class of medical device the regulatory requirements change. Safety, usability, and compliance are critical.
We can support you with technology development, regulatory compliance, documentation and/or preparation for clinical or pre-clinical trial.
Great ideas change lives
When it comes to medtech regulation, we don’t just provide guidance (though we do that too), but assist you to be ready for compliance assessment. As a fully integrated part of your team, we will develop a gap analysis, compile and assess risks and hazards, develop the Technical History File (THF), ensure traceability in your systems and processes.
Great ideas do change lives. We’re privileged to work with some of the best clinicians, consultants, major multinational companies and start-ups. We can be engaged at any stage, from the very start during feasibility through to preparation for clinical investigation.
Rapid product development
Every project is different. We understand your constraints. We’re flexible and work in a way that suits you, putting the right team together to focus on rapid iterative product development while maintaining the rigour of quality, safety and reliability in design.
cGMP standards are increasingly important for medical devices, biotech instrumentation and laboratory equipment. Reference to the cGMP framework which describes best practice is rapidly becoming a requirement. Many labs will not accept non-compliant equipment.
From simple to complex class II electromechanical, and electro optical medical devices great design and development needs fresh thinking grounded in medical technology experience, rigour in testing, validation, verification and qualification to ensure performance and reliability.
Engineering Excellence
Excellence in engineering is at the heart of medical device design for safety and performance. We apply leading-edge techniques, know-how, experience and professional project management.
Precise, well-thought-through design saves time and cost. Experience in solving technical engineering challenges means better quality, safety and reliability.
We use 3D printing for rapid mechanical engineering design prototyping to enable assessment of form factor, fitness for purpose, practicality, usability, robustness as well as product specific requirements.
A well managed project includes design for regulatory compliance, quality and risk, a comprehensive understanding of the requirements, and a formal process-driven approach.