Our team includes experts in medical device regulation who can guide you through CE marking, FDA submission and other regulatory needs for your product.
Our services include:
- Process Validations
- Sterilisation Validation
- Age testing for shelf life
- Transportation Testing
- Bench testing of transport and aging units
- Clinical language verification for instructions for use
- Testing to ISO standards
- Label design
- File compilation and submissions for regulatory approvals.
If you would like to provide you with a regulatory evaluation, contact us now at firstname.lastname@example.org with questions, or phone us at +353 71 91 15111.