Are you applying for 510k approval with the FDA? Do you need assistance with CE marking of your medical device? Do you need advice on regulatory affairs?
Our medical device consultancy provides a major bank of experience for you to tap into. Right from the outset of a project we can advise on the best regulatory pathway to a painless product launch.
What is the best route to registration?
Is my documentation ready for filing?
Have I proved that my medical
product works?
Is
my risk analysis robust?
How
do I prove product safety?
Do
I need a clinical trial?
Is
my biocompatibility data adequate?
We will help you answer these questions and many more!
You will benefit from an extremely cost effective service to the medical device and biotech industry as we do not carry the overheads of a pharmaceutical CRO. We are also able to combine regulatory consultancy with our advisory service on systems and products, alongside the provision of bench test data.
Research and Development
- Material selection and analysis
- Project planning
- FDA submissions
- CE Marking advice
Design
- Risk assessment
- Bench testing
- Ageing studies
Manufacturing
- FMEA
- Pack validation
- Machine Process validation
- Contamination control
Quality Assurance
- Regulatory compliance
- Leak and flow test equipment
