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
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
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
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
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
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