TECHNCIAL DOCUMENTATION

Technical Documentation

YOUR TECHNICAL DOCUMENTATION

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EVERYTHING FOR YOUR Technical Documentation

As a medical device or IVD manufacturer, you are aware of how much know-how is needed to prepare a MDR or IVDR conform Technical Documentation. Of course, your time and financial resources are needed for product development and sales. In other words, you need support to create or review your files quickly and for a reasonable price. We offer you both! Check out all the options regarding Technical Documentations below.

TEMPLATES

Profit from our up-to-date MDR/IVDR compliant templates. Guidance texts will help prepare your documents step-by-step. AstraCon’s unique offer: buy individualized templates in your corporate design! With the data already in the correct place, you will just have to fill out the remaining gaps.

GAP ANALYSIS

Our GAP analysis lets you see at a glance which gaps still exist in the technical documentation of your medical device or IVD product. We check whether it is complete, readable and up-to-date. Inconsistencies or obvious discrepancies are reported to you as well. Check out the different GAP analysis plans.

REVIEW

We will do a thorough MDR/IVDR compliance check of single documents or your complete Technical Documentation. We will provide you with a detailed assessment considering the latest harmonized standards and regulations. With our guidance, you will have your documents MDR-/IVDR-ready in no time.

CREATION

We create the Technical Documentation for your medical device or IVD for you. Whether individual documents or the entire Technical Documentation: our experts work quickly, reliably and ensure the highest quality. Audit-ready MDR/IVDR compliant documents are created in close consultation with you.