Time is Money…

And in medical device development, the clock is always ticking.

Our job is to make every second count, to make more progress in less time

Years of experience in the successful development of a diverse range of medical devices has enabled us to develop a portfolio of services.

Services to help you plug the competency gaps in device development, or provide the resource to do the job for you if you don’t have the expertise or resource in house.

Here’s some of the ways we can help you get to market sooner, with less cost, managing risks…

Device Development

We help you generate an exceptionally comprehensive, yet straightforward development strategy that makes your device programme easy to follow.

This may include a range of support and guidance activities, such as:

  • Helping you build your development approach, respecting International Standards and Regulations
  • Piecing together the elements of your project
  • Filling in your Quality System, Process or Usability Engineering gaps

Regulatory Support

We help you ensure regulatory compliance for  your medical device, building it in to every aspect of development.

The regulatory landscape is continually shifting. 

We help you manage those changes through:

  • Selecting an appropriate regulatory strategy
  • Guidance and support for regulatory submissions for EU, UK, US and Canada
  • Technical File / Design History File creation, review and revision

Human Factors

We help you avoid delays to Medical Device projects caused by inadequate Human Factors programmes.

We do this, through a comprehensive range of services that include:

  • Human Factors Engineering / Usability strategy planning
  • Usability plan execution
  • Early stage User Research
  • Formative + Validation study design, execution and reporting
  • Human Factors Summary Report creation

Quality Management

We help you ensure Quality Management  benefits your medical device development, whether you’re just getting started, need to refresh what you’re doing, or need hands on project support. 

We help you manage all this through;

  • Quality System Gap Assessments
  • QMS Design, Implementation & Continuous Improvement
  • Project Quality Gap Assessment
  • Project Quality Plans
  • Technical documentation creation, review and revision

Risk Management

Managing project risks is a key aspect of any Medical Device (or combination product) development project.

We help you integrate risk management  into your development programme:

  • Risk Management Planning
  • Risk Identification & Analysis
  • Design Controls
  • Risk mitigation and reduction
  • Design Verification & Design Validation
  • Risk Management Reporting
  • Post-market surveillance

Skills Development

It can be challenging to ensure your team builds the skills they need to develop your Medical Device in the right way.

We help you develop skills in each of the key disciplines for success, through:

  • In-house delivery of training courses
  • Public training courses
  • Bespoke workshop development and facilitation
  • Coaching & Mentoring
  • Training and Development planning
  • Training Needs Analysis