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Whether you wish to have structural gaps identified as part of a basic review or require a detailed, thoroughly researched content review of your technical documentation: we ensure regulatory compliance and predictability for your product (MDR & IVDR).
Prior to the planned submission to a Notified Body or the FDA, companies regularly face complex regulatory issues regarding their technical documentation:
A lack of clarity and undetected gaps lead to delays, significant additional costs and time-consuming rework later in the authorisation process.
Our team is here for you.
Choose the approach that best suits your current stage – from a formal and structural basic review to a comprehensive, detailed review of the content carried out by our subject matter experts.
We carry out a formal review of your technical documentation against the requirements of the target market. The aim is to determine quickly and reliably whether all legally required documents are present and plausible
Scope of services:
Your benefit: You will receive a clear status report within a short time, know exactly which documents are still missing for submission, and can plan and prioritise the next tasks precisely.
Suitable for you: If you wish to obtain a quick, well-founded overview of the formal completeness of your files and rule out major errors before submission.
This option goes beyond a formal review and combines structural analysis (basic review) with an in-depth review of the content carried out by specialist subject matter experts. Our findings report provides you with the basis for addressing any gaps in the content
Scope of services:
Your benefit: You receive an in-depth substantive assessment of your documentation, know exactly where regulatory requirements and guidelines are not being met, and can plan and prioritise the revision of the content with precision.
Ideal for you: If you require comprehensive substantive validation of your technical documentation for internal stakeholders or for an upcoming international approval (EU/USA).
These services involve simply assessing and identifying gaps. They do not include active support in rectifying these discrepancies. We are happy to provide you with a separate, bespoke quote for this once the gap analysis has been completed.
Let’s arrange a brief, no-obligation initial consultation to determine which testing model best suits your current stage, your documentation and your business objectives.
Phone
+49 7531 94500 20
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