MedTech

Medizintechnik

DHC CONSULTING SERVICES FOR MEDICAL TECHNOLOGY

Although the industry is still considered to be booming, innovative and promising, growth is currently falling off. Medical technology companies are facing great challenges like enormous pricing pressure on products and services, rising commodity prices, increasing regulatory requirements with correspondingly costly quality assurance measures and documentation requirements. For many companies this means additional action with corresponding costs.

Suitable measures to optimize processes in terms of efficiency and cost, as well as quality and compliance management strategies, are required to prepare now for future challenges.

DHC Competencies

As specialists in “Best in Class” processes in medical technology, in addition to our core competencies we can advise you on the following topics:


Introduction / implementation of Unique Device Identification (UDI) with SAP

UDI is a unique code which contains a device ID (DI – Device / Product Identifier – GTIN), a production ID (PI – Production Identifier) and includes current production information for this device.

DHC supports you in the

  • definition of the specific UDI requirements
  • identification of the necessary data
  • creation of the data model for labels and for transmission to the GUDID
  • implementation in SAP
  • definition and implementation of labeling requirements (e.g. new barcodes)
  • validation of the implementation

Learn more about our consulting services for Unique Device Identification (UDI) with SAP.


Optimization and standardization of business processes and IT systems through the implementation of SAP S/4HANA

for:

  • Supply Chain Management
  • Sales
  • Manufacturing
  • Procurement
  • Warehouse Management
  • Quality Management
  • Plant Maintenance
  • Finance
  • Human Resources

Learn more about our consulting services for SAP S/4 HANA implementation


Design and implementation of software validation

for e.g.:

    • ERP systems
    • SAP
    • Oracle applications
    • Microsoft Dynamics AX/NAV
    • Document management systems
      • EMC Documentum incl. special user interfaces with QUMAS, DocCompliance, First Doc, McLaren, C6
      • Saperion
      • ELO
    • CAQ systems
      • Babtec
      • IBS
      • SAP QM
      • Böhme & Weihs
      • IQS
      • IT service management systems
        • SAP Solution Manager
        • HQ Quality Center
        • BMC Remedy Action Request System
        • Frontrange ITSM
      • Pharmacovigilance systems
        • ARISg
        • PV Works
        • Adam&Eve
      • in-house developments
      • facility management systems

Learn more about our consulting services for Software Validation/Computer System Validation (CSV)


Implementation of a standardized CAQ system with SAP QM

for the following processes:

      • Quality planning (APQP, FMEA, Control Plan, Inspection Planning)
      • Quality control (incoming goods inspection, in-process control, release tests, suppliers’ certificates)
      • Quality costs
      • Product release
      • Certificates of analysis
      • Supplier qualification incl. first article inspection
      • Management of test equipment
      • Quality evaluations
      • Audit management

Learn more about our consulting services for CAQ with SAP QM


Introduction of a global deviation management system based on SAP Quality Issue Management (QIM)

for:

      • Customer complaints incl. 8-D report
      • Internal problem reports
      • supplier complaints
      • audit findings[/CHECK]

      Learn more about our consulting services for  SAP Quality Issue Management (QIM).


Implementation of an integrated SAP IT Service Management in SAP Solution Manager

with

      • end user support (incident management, problem management, request fulfilment)
      • implementation support by project and document management
      • managing global templates
      • IT change management (incl. transport management and release management)
      • test management
      • access management
    • Learn more about our consulting services for SAP Solution Manager.


Project and Change Management for SAP projects

      • Project organization
      • Detailed project planning with work package definition
      • Transformation concept
      • SAP scoping
      • Project Manual
      • Business Process Management with process architecture as a backbone for the project
      • Operational Project Controlling with project progress and budget monitoring
      • Selection of SAP consultants and developers
      • Development concept: local, nearshore, offshore
      • Project Quality Management
      • Project Risk Management
      • Project Management Office

Learn more about our DHC Method.


Development and implementation of a Business Process Management

      • Development of a BPM approach especially for SAP
      • Training and implementation of BPM
      • Establishment of a process architecture
      • Modeling of business processes
      • Integration of the DHC Best Practice Processes
      • Introduction of BPM software DHC VISION
      • Integration of SAP Solution Manager in the BPM concept
      • Integration of SAP Business Process Repository

Learn more about our DHC Method.

WHY CHOOSE DHC?

Each industry has its special features and specific requirements, such as the relevance of particular economic, legal and political circumstances, specific requirements for quality and safety, and so forth.

This is why we supplement our core topics of

with our own, industry-specific consulting services. These services are based on our broad-based process know-how, combined with our long experience in the relevant sectors. This secures a long-term competitive advantage for your business.

eigene branchenspezifische Beratungs-Lösungen für die Medizintechnik. Grundlage hierfür ist unser breites Prozess-Know-how, verbunden mit einer langjährigen Erfahrung in der jeweiligen Branche. Damit sichern wir Ihnen einen nachhaltigen Wettbewerbsvorteil.

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

Customers

WEBINARS AND EVENTS

28. Juni
German Webinar

Managed Services in der Validierung

Möglichkeiten und Grenzen der Computervalidierung als Managed Services (kalkulierbare Alternative zu eigenen CSV Ressourcen)

more
05. Juli
German Webinar

Effiziente Einführung von SAP S/4HANA im regulierten Umfeld

Welche Parameter beeinflussen Projektkosten/-erfolg der SAP S/4HANA Implementierung sowie die Wartbarkeit von System und validem Zustand?

more
08. August
German Webinar

DHC Roadmap zu SAP S/4HANA für die Life Sciences

Vorstellung der Vorgehensweise aufzeigen sowie Vermittlung eines ersten Eindrucks, wie der Weg einer digitalen Transformation aussieht.

more
06. September
German Webinar

Datenintegrität und computergestützte Systeme

Vorstellung der Anforderungen an die Datenintegrität computergestützter Systeme gemäß ALCOA sowie deren Umsetzung in Validierung und Betrieb.

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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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DHC WEBINARS

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