The new Medtech EU MDR/IVD regulations published at the end of May pose a major strategic and operative challenge to the entire industry, and they will have a major impact on the business performance of many companies and SMEs. All companies are strongly challenged. The first stakeholders have prepared GAP analyses to realize the tight implementation requirements by 2020 (MDR) and 2023 (IVDR). There are more questions than answers at this time, especially as the interpretations of the legislation have not yet been established. This is further complicated by the fact that there is a looming shortage in Switzerland for the resources requirements (an estimated 1,400 skilled workers) and in the operative budget of Swiss companies (from up to 400 million Swiss francs per year). (Source: Concep+)
 
The event, which is jointly organized by BaselArea.swiss and Health TechCluster Switzerland, brings together leading experts from the industry and the services sector to discuss the current situation and possible solutions. Using facts, practical examples and stimulating concepts, the presentations and panel discussions will serve as a platform for all those involved to exchange ideas on practical solutions and plans for action.

The event addresses decision-makers in the medical technology sector.

Date: January 30th 2018, 17:00
Location: Halle 7, Gundeldingerfeld, Dornacherstrasse 192, 4053 Basel 

More Information about this event can be found here.

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?
Frederic Kaiser Website

Frederic Kaiser
Product Manager

Tel. +41 32 513 67 78 | Mail