MDR & IVDR Compliance

Master the challenges
of MDR and IVDR!!

GxP 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
Request information!

Learn more about our consulting services for GxP Compliance!

WEBINARS AND EVENTS

28. Januar
Web session (in German)

Validation of SAP S/4HANA on-premise and Private Cloud Edition

The webinar looks at the validation requirements for SAP S/4HANA on-premise vs. cloud systems.

more
04. Februar
Web session (in German)

UDI: Implementing global requirements with the right strategy and software

Implementation of the UDI requirements based on the SAP Cloud Platform with the UDI Platform of p36

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10. Februar
Web session (in German)

Your journey to the secure Microsoft Cloud for Pharma, Medical Technology and Biotech

Overview of the key success factors for security on the path of regulated companies to the Microsoft Cloud

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11. Februar
Web session (in German)

New ISPE GAMP® Good Practice Guide: Enabling Innovation

What does the new ISPE Guide mean for Computer System Validation (CSV) or Computer Software Assurance (CSA)?

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18. Februar
Web session (in German)

QM in S/4HANA – Example of an integrated LIMS in a Customer Project

Presentation of the quality-relevant processes of a LIMS in a customer project with the help of SAP QM as an integrated overall solution.

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10. März
Web session (in German)

SAP S/4HANA Implementation and Validation in Life Sciences

Find out what benefits the LSA approach offers you for the optimal, validated deployment of S/4HANA.

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DHC WEBINARS

Our webinars are provided as a free service for DHC customers and potential customers.