THE GROUP
The New Level Group provides services and professional consultancy operating in the public and private sectors both in the UK and internationally.
>> read moreCLINICAL TESTING
- Establish a “design control” framework
- Decide on Target Markets
- Review Country Regulations
- Undertake Clinical Review
- Set up a Clinical Trial (if necessary)
- Perform a Clinical Evaluation
- Per from Lab Test
- Labeling & Information for use
- CE mark application & approval
- ISO13485/FDA approval