Do you need help with:
- Compiling and reviewing device technical documentation?
- Completing the regulatory submission process?
- Review and Gap Assessment of technical files?
- Maintenance of technical files?
- Construction of technical files?
- Correction of technical files?
- Line Extensions?
- Resubmissions of technical files?
- Building and maintenance of company CE Technical Files in relation to the GSPR meeting the Declaration of Conformance under Regulation and harmonised Standards?
- Clinical Study Reviews to ISO 14155 (Class IIb and Class III)?
- Biocompatibility study review to ISO 10993?
- Standard Operating Procedure for (EUDAMED) Modules/UDI?
- Support around meeting the Conformity Assessment route?
- Technical Files? When was your last annual review?
For any manufacturer, overcoming regulatory hurdles is essential for gaining access to new markets and business growth.
We can help with identification of regulatory requirements for global markets along with preparation of submissions for countries such as Canada (MDEL), US 510(k)s Australia, Japan, and the Middle East.
Contact QAEC Limited to see how we can help you