Although the European Commission postponed the entry into force of the Medical Device Regulation until May 2021, this is not a good excuse for delaying activities; indeed this additional 1 year period should be used to further check the compliance of the Technical Files with the new requirements and plan any needed activities.
RPN can support you with technical file gap analysis that:
- are effective and efficient in identifying all gaps
- cover all aspects (technical, clinical, biocompatibility)
- are easy to understand
- allow easy planning of activities
Don’t get caught unprepared and contact us for your customized gap analysis; you will safe time, money and you will be able to better plan the future of your devices.
Regulatory Pharma Net offers full regulatory support and is available for any clarification and assistance, please do not hesitate to contact us!