TECH-DOC

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.

 

Templates for your Technical Documentation

Creating the Technical Documentation for your medical device or IVD product can be a complicated and time-consuming affair. It doesn’t have to be: we offer you templates with guidance.  What’s more, we offer individualized templates. Overall, this AstraCon unique feature allows you to finalize your documents even quicker.

Individualized templates

AstraCon offers a unique feature for technical documentation templates. Fill out the form and choose one, two or multiple templates. We will check the form and you will then receive a short list with information snippets. After you provided us with this information and your corporate identity, we will send you back your individualized templates in your corporate design! Your data is already in the correct locations. All you have to do now is fill in the remaining gaps.

GAP Analysis of MDR/IVDR Technical Documentation

A quick check for manufacturers, investors, and EC representatives!

Because many stakeholders are unsure about the quality and completeness of the Technical Documentation, we decided to offer a quick check. With this so called “GAP analysis” we systematically check, if your Technical Documentation is complete, readable (e.g. language, searchable), and up-to-date. Additionally, inconsistencies or obvious discrepancies catch the eye of our experts and are included in our report to you.

Since the Technical Documentation is the regulatory heart of your medical device or IVD product (MDR/IVDR), you need to know about all the gaps. Our GAP analysis will give you a comprehensive overview. This will enable you to focus on the biggest issues and gaps.

This is not only important if you are a manufacturer and therefore in the possession of your own Technical Documentation. It might also be important, if you are an investor or EC representative and you are unsure, if the quality of the documentation of your partner company is sufficient.

"The technical documentation shall be presented in a clear, organised, readily searchable and unambiguous manner."

– MDR/IVDR, Annex II –

CLEFT

STARTER
500
  • what we check:
  • all documents existing?
  • documents readable?
  • documents up-to-date?
  • striking discrepancies?
  • what you get:
  • deficiency report

CANYON

ADVANCED
2.000
  • what we check:
  • all documents existing?
  • documents readable?
  • documents up-to-date?
  • striking discrepancies?
  • what you get:
  • detailed checklist with
    comments & instructions
  • official guidance documents
  • documents sorted into MDR/IVDR file structure

VALLEY

EXPERT
4.000
  • what we check:
  • all documents existing?
  • documents readable?
  • documents up-to-date?
  • striking discrepancies?
  • what you get:
  • detailed checklist with
    comments & instructions
  • official guidance documents
  • documents sorted into MDR/IVDR file structure
  •  
  • SPECIAL TD OVERVIEW*
Special Offer

* The “TD Overview” document is a summary and reference document, that gives you and the auditor a clear and structured overview over the contents of your complete Technical Documentation (Annex II and III MDR/IVDR).

Document Review

Sometimes, however, a quick check might not be enough for your purposes. Instead, you may need a detailed MDR or IVDR compliance check. In this case, a document review performed by our experts might me a better option. During the review process, our experts will check if all requirements of MDR/IVDR regulations, from applicable harmonized standards, as well as acknowledged guidance documents are fulfilled. This will enable you to get your documentation Audit-ready quickly and efficiently.

For a detailed MDR-/IVDR compliance check of single documents like the CER or your risk management file, please check out our review options.

Tech-Doc Creation

Let our experts do the work for you!

MDR/IVDR-ready Documents

You need Technical Documentation for your EU market launch? However, the road ahead is just too daunting right now? In this case, let us ‘be your lift’! Whether individual documents or the entire Technical Documentation: our experts work quickly, reliably and ensure the highest quality. Audit-ready documents are created in close consultation with you.

The Technical Documentation is comprised of a variety of different documents:

There are very short and rather simple documents like the “Declaration of Conformity” (like Pebbles), medium sized documents with moderate complexity like the “PMS Plan or Report” (like Stones & Boulders) and then there are long and complex documents like the “Risk Management File” or the “Clinical Evaluation” (like Hills). Additionally, of course, there is also the complete Technical Documentation (like a Mountain) with all the essential documents.

Category "Pebbles"

  • Declaration of Conformity
  • Intended Purpose
  • Statement for systems / procedure packs
    (MDR, Art 22)
  • Declaration on particular substances (animal, human, medicinal)

Category "Stones"

  • Classification statement
  • PMS plan
  • PMS report

Category "Boulders"

  • Instructions for use (IFU) and Labelling
  • GSPR checklist and List of applicable standards
  • Biological evaluation plan and report (MDR)

Since we need an in-depth knowledge of your product to create one of the “BOULDER” documents, we initially perform a GAP analysis “CLEFT“. Your benefit: together with the newly created documents you will also receive a deficiency report of all GAPs in your Technical Documentation.

Category "Hills"

  • Clinical Evaluation Plan and Report including Literature Search
  • Risk Management including Plan, Analysis and Report

Since we need an in-depth knowledge of your product to review one of the “HILL” documents, we initially perform a GAP analysis “CLEFT“. Your benefit: together with the newly created documents you will also receive a deficiency report of all GAPs in your Technical Documentation.

Category "Mountain"

We review the complete Technical Documentation of your medical device or IVD product.