MDR & IVDR Compliance

Master the challenges
of MDR and IVDR!!

IT Compliance

Medical Device Regulation (MDR) and IVDR Compliance

The Medical Device Regulation 2017|745 and IVDR 2017|746 enter into force on 26 May 2020 and 26 May 2022, respectively. These regulations will have far-reaching repercussions for the manufacturers of medical and in vitro diagnostic devices. Our industry specialists help you to make the necessary preparations – not only drawing on their long experience but also applying their intuitive understanding of legislative changes.

Take action now – don’t wait to be surprised by the changes in the law!

POTENTIAL ACTION REQUIRED FOR COMPLIANCE WITH THE MEDICAL DEVICE REGULATION AND IVDRR

  • In some circumstances, medical devices and accessories must be assigned to new risk classes
  • Updates to technical documentation
  • New responsibilities for certain economic operators
  • Setup of a UDI system
  • Interface to Eudamed (European database for medical devices)
  • Application of the new regulatory requirements for clinical testing, since clinical data and trials will in practice now be less accepted according to the equivalence principle

GETTING STARTED WITH THE MEDICAL DEVICE REGULATION/IVDR/IVDR

Awareness Workshop

We introduce you to the key aspects of the new MDR and IVDR regulations, and what important changes they have now introduced.
We also relate this information directly to your specific environment and inform you of any need for action.

Compliance Check

We analyse your compliance status:  what is your status quo – and what do you still need to do?
The results are presented to you as a compliance roadmap with recommendations for implementation, an estimate of effort and a rough schedule.

 

WHY CHOOSE DHC?

We provide you with support for the following:

  • Setup/adjustments to post-market surveillance
  • Setup/adjustments to post-market clinical follow-up Compliance and implementation of regulatory requirements and standards
  • UDI and Eudamed implementation
  • Inclusion of interfaces in/to your ERP system
  • Revision of technical documentation
  • Setup/adjustments to QM system
  • Process adjustments in CAQ systems (especially SAP QM)
  • Preparation/execution of internal as well as external audits
  • Adjustment/optimisation of vendor management
  • Adjustment/optimisation of document management
Germany
Matthias Bothe

Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0
email: matthias.bothe@dhc-gmbh.com

Matthias Bothe, DHC GmbH
Switzerland
Carsten Buri

Director Sales & Marketing
phone: +41 44 500 888 7
email: carsten.buri@dhc-ag.ch

Carsten Buri, DHC AG
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WEBINARS AND EVENTS

08. November
German Webinar

Prüfmittelverwaltung und -überwachung mit SAP

Vorstellung der in SAP integrierten Prüfmittelverwaltung mit allen Funktionen für die unternehmensweite Verwaltung betrieblicher Prüfmittel

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12. November
English Seminar

SAP: Validation and GMP Compliance

Seminar with speakers from DHC GmbH, organized by Concept Heidelberg on behalf of the ECA Academy, Steigenberger Hotel Berlin

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22. November
German Webinar

Validierung von SAP S/4HANA Enterprise Management

Neue Compliance Aspekte und Wege zu SAP S/4HANA sowie Vorstellung der prozessorientierten, risikobasierten DHC Methode auf Basis von SAP Activate

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29. November
German Webinar

APQP, FMEA und PLP mit SAP QM

Vorstellung der verschiedenen SAP Werkzeuge zur Abbildung von APQP und Darstellung von SAP PPM, FMEA, Kontrollplan, Prüfplan und Qualitätsmeldung

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06. Dezember
Webinar

SAP QM als integriertes Laborinformations- und Managementsystem (LIMS) in der Life Sciences

Vorstellung von LIMS-Funktionen des SAP QM sowie Integrationsaspekte zu Einkauf, Lagerung, Produktion und Vertrieb

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