To ensure your EU Technical File and Design Dossier is complete and compliant, QCS can assist you with the certification process on all aspects including:
- Design records and validations
- Formal classification reports
- Detailed risk management studies to ISO 14971
- Clinical efficacy and safety reports to Guidance MEDDEV 2.7.1:rev 3, December 2009
- Clinical evaluation: A guide for manufacturers and notified bodies
- Essential requirement check lists creation/review
- Preparation of Declarations of Conformity
- Approvals of labels and instruction sheets including 3rd party checked medical translations
- Own-branding from 3rd party manufacturer
- Product registration
- Working with you alongside the notified body of your choice