The legal manufacturer is responsible for making sure their technical documentation is up to date and compliant. If your files were prepared according to the Directives, if some time has passed, or new applicable standards have been released that you rely on for compliance, you should review your files.
If you, as the legal manufacturer, do not have the resources internally, we, (Advena) have a skilled and experienced team of consultants who are ready and able to assist in providing you with a gap analysis service.
The normal approach for this will be to undertake a review or gap analysis of your existing technical documentation (Technical Files) and compare against the requirements of the regulation you wish to be compliant with.
Upon completion of the Gap Analysis, Advena will prepare a comprehensive report which shall highlight any deficiencies or nonconformities against referenced requirements and provide suggestions on how to close these gaps.
In addition, and based upon our report, we shall also provide a quotation for Advena to bring your documentation in line with the requirements of the regulation you wish to comply with.
Such a gap analysis can be applied to your whole technical file or to sections such as the Clinical Evaluation section or Risk Management section, or as you require.
Similarly, a gap analysis can be applied to your Quality Management System (QMS) particularly as there is now a strong link between QMS and the new Regulations.
Our consultants may also assess existing verification and validation documents (e.g. ISO 10993 biological evaluation test reports) against the most up to date standards in order to highlight any gaps with respect to new requirements.
Advena are able to undertake such gap analyses in an expert and cost-effective manner to assure legal manufacturers do not start making changes that are not necessary or not appropriate.
For more information, please contact us.
