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ARIAQ et ISS AG proposent une formation d’une demi-journée pour les fabricants de dispositifs médicaux dont l’objectif est d’illustrer les exigences des évaluations cliniques selon « MEDDEV 2.7/1, Révision 4 » par des exemples concrets de mise en application en Suisse.

Actuellement, la création d’une évaluation clinique est un défi pour l’industrie. Cette formation offre un programme ad hoc vous permettant d’acquérir les connaissances fondamentales pour relever ce défi.

Description générale

Conformément aux attentes, la dernière révision du document concernant la phase d’évaluation clinique des DM publiée par la Commission Européenne est plus complète. Plus précisément, le document présente de manière plus détaillée un certain nombre de cas afin de clarifier des exigences préexistantes. L’accent est particulièrement mis sur le travail à effectuer par les fabricants pour l’organisation de tests cliniques fiables. Il s’agit donc de démontrer la validité scientifique des conclusions basées sur un traitement irréprochable des données.

ARIAQ et ISS proposent une formation dont le but est d’illustrer par des exemples pratiques comment les fabricants de DM peuvent répondre aux exigences du MEDDEV Rév 4.

Le programme
  • Importance des données cliniques pour les fabricants de dispositifs médicaux
  • Les exigences réglementaires en Europe
  • MEDDEV 2.7/1 - Lignes directrices pour les fabricants et les organismes notifiés
  • MEDDEV 2.7/1 Révision 4 - Quels sont les changements principaux?
  • L'évaluation clinique après MEDDEV 2.7/1 Révision 4 (Partie 1)
  • Définition du scope: Planification, Questions, Équivalence
  • Recherche et compilation de la littérature et des essais cliniques
  • L'évaluation clinique après MEDDEV 2.7/1 Révision 4 (Partie 2)
  • Examiner et analyser les données pertinentes
  • Création d'un rapport d'évaluation clinique (structure, contenu)
  • Possibilités et limites utilisant un produit équivalent
  • Pierres d’achoppement typiques durant les audits
  • Est-il obligatoire de faire une évaluation clinique pour une approbation ?
  • Des études „suivi clinique post-commercialisation (PMCF) “ sont-elles nécessaires?
  • Importance de l'analyse des risques dans l'évaluation des données cliniques pour les dispositifs médicaux

Les données de formation

Date:  Le 29 mars 2017
Heure: De 13.30 à 16.45
Lieu : ARIAQ SA, Rue Galilée 5, 1400 Yverdon-les-Bains
Langue: Français, documents en Anglais
Frais : CHF 340.-
Contact Secretariat ARIAQ: Inscription par tel: +41 (0)24 423 96 50
  Inscription par E-Mail à: This email address is being protected from spambots. You need JavaScript enabled to view it.                                   

 

Les places sont limitées!

Article about REGULA™

In the November 2016 issue of the journal DeviceMed you can find an article about REGULA™. This article was one of the most read DeviceMed articles in November 2016.
DeviceMed Article about REGULA™ (German)

REGULA™ - Features Overview

Submission Management

➔ Electronic management of submissions and timelines
➔ Centralized management of information and data
➔ Guided process for initialization of new submissions

Permanent Tracking

➔ Approved products (market coverage)
➔ Pending registrations (in work)
➔ Countries where selling is explicitly blocked

Warning Management

➔ Expiring registrations
➔ Stalled registrations
➔ Expired registrations

Re-Registration with a few clicks

➔ Simple re-registration process
➔ Only a few clicks needed
➔ Keep or discard documents
➔ Automatic archiving of old registrations (inactive)

Country Templates

➔ Save your experience
➔ Create your own country templates for future registrations
➔ Purchase templates of ISS AG, Integrated Scientific Services

Automatic Reporting

➔ Create your specific management reports
➔ Save your most frequently used reports
➔ Create and send reports periodically and automatically to defined people
➔ Export your reports to CSV

Embedded Task Management

➔ Management of to-do’s
➔ Assign tasks to people
➔ Progress control of tasks

Simple Submission Compilation

➔ Collection of submission content in a ZIP-File
➔ Creation of an automatic PDF index e.g. according to STED
➔ Choose the hierarchy within the ZIP-File (flat or chapters)

Knowledge Management

➔ Place information and comments on each level
➔ Inform colleagues about important information
➔ Conclude phone calls in a brief submission comment

Benefits of REGULA™

  • Time saving in initial registrations
  • Documents are available in REGULA™
  • Possibility to work with templates
  • Key information about the country available
  • Time gaining in re-registrations process
  • Keep products of base registration
  • Keep existing/valid documents of base registration
  • Easy replacement of documents/products
  • Automatic archiving of foreign registration
  • Time saving in retrieving documents
  • Many filter possibilities
  • Well thought out search feature
  • (e.g. to which countries has a specific document been submitted)
  • Good versioning / history
  • Reduction of questions to RA department
  • Creation of specific management reports
  • Automatic creation and sending of specific reports to defined people
  • Viewer right for selected people
  • Risk reduction of missed deadlines
  • Warning when submissions expire soon
  • No submissions fall unintentionally into oblivion
  • Simplification of the labor division
  • RA-Task management directly in REGULA™
  • Comments and information can be placed on each level
  • Improvement of project management
  • Overview of responsibilities
  • Overview of market priorities
  • Creation of specific project reports
  • Time saving in getting submission information
  • What is the current market coverage
  • Which submissions are currently in work
  • Where is a specific product approved in the world
  • etc.

REGULA™ - Implementation process

We consider each REGULA™ introduction as a project and for each introduction we work through the following steps:

1. Demo / Preparation

2. Workshop on site

3. Development of prototype

4. Testing phase

5. Final adjustments

6. Introduction training

As we are owner of the source code customizing according to customer wishes is possible.

The duration of a REGULA™ introduction depends on the complexity of the customer’s situation.
Experience value: 3-9 months

REGULA™ will be installed on your own IT-infrastructure.

REGULA™ allows data interaction via interface to third-party systems. Visualization:

System requirements

The system requirements are depending on the complexity of the customer’s structure, the number of users and the data volume intended to be stored in REGULA™.

The installation of REGULA is done on a dedicated server (windows or Linux). Detailed server requirements and the installation process are defined during the introduction project.

The access to REGULA™ is done via web browser. For an unrestricted use of REGULA™, JavaScript needs to be activated in the browser.

REGULA™ - The Investment

Initial cost

REGULA™ is not just a software, it is a project. Based on foreign projects the cost constellation is as follows:

Recurring cost

The recurring costs are calculated on the initial investment and on other factors:

Six reasons for REGULA™

Reduction of time to market

➔ Approve your products earlier on the market by using REGULA™
➔ Be faster than your competitors in getting market presence

Reduction of business risks

➔ No submissions fall unintentionally into oblivion
➔ Permanent tracking of submitted content
➔ People are informed at anytime
➔ Products are only sold to countries where selling is allowed in

Increase of turnover

➔ The earlier you get the approval on the market the faster you can begin to sell

Improvement of efficiency

➔ More efficient and structured working in daily business
➔ REGULA™ pushes your employees to work disciplined

Enhancement of transparency

➔ Get a better and transparent overview of your regulatory affairs activities
➔ REGULA™ presents information understandable for everyone.

Standardization of your RA Structure

➔ The introduction of a REGULA™ system can be a good opportunity to analyze the existing companywide structures and processes as well. Perhaps there is much room for improvement?

REGULA™ - Your contact

Are you interested in more information about REGULA™ or do you wish a live-presentation of the application?
Hansjörg Riedwyl Website

Hansjörg Riedwyl
CEO

Tel. +41 32 513 67 66 | Mail