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References

Technical

SNCF

Broadcast dynamic documentation on a tablet

RTE

Ensure the up-to-date status and consistency of all maintenance procedures

EDF

Graph-oriented database: manage a mapping of the entire document structure

Supersonic

Supersonic: innovative medical imaging equipment

PDF Publishing TIL Technologies:

PDF publishing of technical and training documentation

Updating documents Activence

Updating manuals and technical data sheets.

PMB

Precise structured documentation for Nuclear, Research, Defense and Space.

Axess

Axess Technology: automated production and management of online manuals

Computing / Software

For many software vendors, Calenco is the solution for establishing and maintaining online help for their solutions

  • Easy to use for the final user
  • Enhances the user experience
  • Important time savings for the technical writer
  • Simplified updates

Ingestic

INGESTIC: advising and implementing sustainable IT solutions

Olea Medical

Must-have reliable and multilingual software documentation!

Pytheas

Pytheas

Itiviti

Itiviti: producing quality documentation fast

Marketing/Sales

Automatic quote management

Provence Impressions: manage quotes, satisfy construction customers

Medical sector

Conformity of documentation for medical devices

Abstract

The structured writing allows meeting requirements of standards on medical devices

Major challenge

Medical field actors face drastic regulation and must meet the requirements of this complex and changing environment.

The European medical community is currently challenged with the recent regulatory provisions made in the context of continuous movement for transparency. They are provisions of the the European medical device regulation 2017/745 (MDR) that replaced the 93/42/CEE directive on May 26, 2021. The objective of this new regulation is to reinforce the medical device flow and traceability and to have greater transparency on product information available for the concerned audience.

Regulatory and technical documentation requirements

One of the main challenges for the manufacturers using the CE mark to sell their medical devices in Europe concerns the product documentation aspect.

Indeed, the manufacturers must edit and update technical documentation : instructions for use, technical files...

Other documents must meet as well the requirements of the MDR: clinical evaluations, labels, declarations of conformity, sales supports, economic operator contracts...

Editing and updating the documentation challenge is completed with the translation management to meet relevant requirements from different EU member states.

The solution of document production comes to the rescue

Calenco, the SaaS solution of structured writing, is accessible to any professional producing contents.

The Calenco tool supports all documentary database to help medical device manufacturers to:
  • quickly produce product documentation,
  • manage update cycles with respect of interlinkage between the documents,

  • customize the documentation according to a user profile, product, country of destination,

  • manage all versions in all languages,

  • ensure consistent quality in accordance with the company's graphic charter,

  • disseminate product documentation on different media (paper, PDF, web, tablets...).

Advantages of the Calenco tool

Here are some examples of requirements and the Calenco offer to facilitate compliance with MDR:


What the customers, medical sector specialists, say

We have been working for many years with companies subject to stringent regulations to deploy our solution.

Discover the project carried out for our customer Supersonic, manufacturer of medical imaging systems.

Discover the testimonial of our customer Soluscope, leader in flexible endoscope hygiene.

Soluscope logo
DL Santé logo
Supersonic Imagine logo
Hücker & Hücker logo
Dedalus logo
Softway Medical logo
Smart Rx logo
Cegedim logo

Edition - Press

On-demand publishing

The D-BookeR publishing house

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