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.
Scroll down to read about our services
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.
Scroll down to read about our services
Our services include:
Project Management
We help you generate an exceptionally comprehensive, yet straightforward development strategy that makes your device programme easy to follow, including helping you build your development approach, piecing together the elements of your project or filling in your Quality System, Process and Usability Engineering gap
Read More...Quality Management
We help you ensure Quality Management is a benefit to your device programme, building compliance into every aspect of development. The regulatory landscape is continually shifting, we help you manage those changes through; Quality Programme Gap Assessments, QMS Design & Implementation, QMS Development & Continuous Improvement, Quality Plans, Regulatory Amendments, QMS Scope Expansion, Quality System & Regulation Training.
Read More...Our services include:
Project Management
We help you generate an exceptionally comprehensive, yet straightforward development strategy that makes your device programme easy to follow, including helping you build your development approach, piecing together the elements of your project or filling in your Quality System, Process and Usability Engineering gap
Read More...Quality Management
We help you ensure Quality Management is a benefit to your device programme, building compliance into every aspect of development. The regulatory landscape is continually shifting, we help you manage those changes through; Quality Programme Gap Assessments, QMS Design & Implementation, QMS Development & Continuous Improvement, Quality Plans, Regulatory Amendments, QMS Scope Expansion, Quality System & Regulation Training.
Read More...Our services include:
Human Factors
We help avoid delays to Medical Device projects caused by inadequate Human Factors programmes, through a comprehensive range of services including; Human Factors Engineering/Design Integration, Human Factors Planning, Integrating User Needs, Human Factors & Risk Management, Formative Testing & Validation Testing, Programme Gap Analysis, Usability Risk Analysis, Human Factors Engineering File Manageme
Read More...Risk Management
Managing project and regulatory risks is a key aspect of any Medical Device development project. We help you integrate risk management processes and activities into your development programme, through; Risk Management Planning, Risk Analysis, Harms & Hazard documentation, Design Controls, defining User Needs and Design Inputs, identification of Risk Control evaluation activities to mitigate & reduce product risk, creation of Design Outputs; Design Verification and Design Validation.
Read More...Our services include:
Human Factors
We help avoid delays to Medical Device projects caused by inadequate Human Factors programmes, through a comprehensive range of services including; Human Factors Engineering/Design Integration, Human Factors Planning, Integrating User Needs, Human Factors & Risk Management, Formative Testing & Validation Testing, Programme Gap Analysis, Usability Risk Analysis, Human Factors Engineering File Manageme
Read More...Risk Management
Managing project and regulatory risks is a key aspect of any Medical Device development project. We help you integrate risk management processes and activities into your development programme, through; Risk Management Planning, Risk Analysis, Harms & Hazard documentation, Design Controls, defining User Needs and Design Inputs, identification of Risk Control evaluation activities to mitigate & reduce product risk, creation of Design Outputs; Design Verification and Design Validation.
Read More...