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FUTURA

Complete technical documentation for medical devices in one database.

FUTURA is your compact solution for the smooth provision for your technical documentation of medical devices according to MDR 2017/745.

Technische Dokumentation für Medizinprodukte gem. MDR 2017/745

Big Data Management

processing large, complex data volumes

time-saving

One database

secure data storage

heterogeneous becomes homogeneous

Timeless documentation

continual updates and maintenance

Always UP TO DATE

FUTURA provides

full content of a technical file

for generic medical devices

MDR 2017/745 Anhang II - Produktverifizierung & -validierung MDR 2017/745 Anhang II - Produktverifizierung & -validierung

Our toolbox

The aim of the new MDR is to ensure safety while
supplying innovative medical devices for patients and users.

So can we!


FUTURA Big Data Management
Our Big Data Service...

... secures your know-how in a data center located in Europe.

... your data under control: provision of information as per your instructions, only.

... provides your customers and their Notified Bodies with all required information - up-to-date, validity-monitored and reliably distributed after updates.




MEDAGENT Lösungreliable.

MEDAGENT Lösungcentralized

MEDAGENT Lösungcomprehensive

FUTURA Tech File Service



... all in one system


MEDAGENT Lösungcomplete

MEDAGENT Lösungup-to-date

MEDAGENT Lösungextendable

MEDAGENT Lösungcustomisable

FUTURA MDR 2017/745 Anhang II

Modular
Technical
Documentation

For generic medical devices a vast part of the technical documentation can be generated and maintained generically, hence limitted need to invest in individual compilation and maintenance.

Multiple use of generic content.

Basismodule und Funktionsgruppenmodule Basismodule und Funktionsgruppenmodule

Basic modules:

  • Summary
  • Superordinate standards, laws, regulations
  • Information from the production
  • Material specifications
  • Labelling requirements
  • Generic information on product design
  • Generic Risk Management
  • Biological evaluation
  • Validation Processing (cleaning, disinfection, sterilization)
  • PMS-Plan

Function group modules:

  • Summary
  • Product list
  • Declaration of conformity
  • Safety & performance requirements
  • Product-specific standards
  • device master records
  • Risk Management
  • Clinical evaluation
  • PMS reports

Reprocessing
validation

To meet reprocessing requirements of MDT more than 14,000 medical devices have been analyzed. Representative devices have been chosen, tested in qualified labs and validated to confirm reprocessability.



Aufbereitungsvalidierung

FUTURA

A project with a 14 week time line.

FUTURA Zeitplan

Maintenance, update, extension

  • Ongoing maintenance - always up to date
  • Integration of feedback from notified bodies and authorities
  • Addition of new functional groups
  • Inclusion and updating of standards
  • Detailing and individualization of risk analyses
  • Addition of further generic medical device groups (risk class I, Ir, Im, Is, IIa, IIb, III)
  • Extension of validation testing, if required
  • Revalidation
  • Annual creation of PMS reports with your data and FUTURA benchmark
  • Documents in different languages, instructions for usw in 21 languages
  • Licensing for marketing authorisations outside the EEA
  • Provision of documents in look & feel of the manufacturer
  • etc.

your benefits

  • Adjustments based on feedback from notified bodies and authorities are available to all
  • Time and cost savings are quickly achieved through systematic, generic preparation of the documents
  • Use of a data master with several thousand medical devices
  • Less effort but more benefit: MEDAGENT takes over 80% of the tasks for creating technical documentation
  • Updates simultaneously for all manufacturers & producers
  • Provision and transfer of reprocessing validation results and reports
  • Your data under control: Provision of information as per your instructions, only
 80% weniger Treibstoff - Mit uns sparen Sie bei der Erstellung der Technischen Dokumentation nicht nur Zeit und Kosten sondern auch Energie 80% weniger Treibstoff - Mit uns sparen Sie bei der Erstellung der Technischen Dokumentation nicht nur Zeit und Kosten sondern auch Energie

Questions?

Contact

MEDAGENT GmbH

Griesweg 47
78570 Mühlheim
Germany

Tel.: +49.7463.9954.0
E-Mail: info[at]medagent.de