Medical technology develops and manufactures products, devices and procedures for the prevention, diagnosis and therapy of diseases. In contrast to pharmaceutical preparations, medical products primarily have a physical effect on people. The portfolio is extremely broad and ranges from implants to highly complex diagnostic devices, such as X-ray equipment. However, dressing materials and products for the administration of medicines, such as infusions, also fall into this category. From an IT perspective, the main differences compared to the pharmaceutical industry lie in the production processes, quality management, regulation and service processes.
The enormous price pressure on the industry’s products and services – with rising raw material prices and increasing regulatory requirements – necessitate correspondingly cost-intensive quality assurance measures and documentation obligations. This poses great challenges for medical technology companies and means additional need for action with corresponding costs for many companies.
Suitable measures to optimise processes in terms of efficiency and costs, as well as quality and compliance management strategies, are required in order to prepare for future challenges now.
We have built up deep industry and process know-how and advise along the entire product life cycle:
DHC CONSULTING SOLUTIONS AND SERVICES FOR MEDICAL TECHNOLOGY
As specialists in “Best in Class” processes in medical technology, in addition to our core competencies we can advise you on the following topics:
- Supply Chain Management
- Warehouse Management
- Quality Management
- Plant Maintenance
- Human Resources
Here you will find our consulting services for a fast, secure and compliant implementation of e.g. SAP S/4 HANA.
for the processes:
- Master data (e.g. material master, inspection characteristics, inspection methods, sampling procedures)
- Quality planning (APQP, FMEA, production control plan, inspection plans, reference operation sets, material specifications)
- Quality inspection (inspection lot processing incl. dynamic modification, goods receipt inspection, in-process inspection, release inspections, supplier certificates, QM in sales and distribution)
- Quality costs
- Product release
- Certificates of analysis
- Supplier qualification
- Test equipment management
- Quality evaluations
- Audit management
- Stability studies
- Statistical process control
Here you will find our consulting services on the subject of CAQ with SAP QM.
- Customer complaints
- External and internal problem reports
- Supplier complaints
- Audit findings
- Measures management
- GxP-compliant documentation of deviations with the measures taken
Here you will find our consulting services on the topic of complaints management/8D report, SAP Quality Issue Management (QIM) and SAP Quality Issue Resolution.
- ERP systems
- SAP (S/4HANA, ECC, Business One)
- Oracle Applications
- Microsoft (Navision, D365)
- Cloud-based systems
- Cloud infrastructure service providers
- Amazon Web Services
- Microsoft Azure Cloud
- Manufacturing Execution Systems (MES)
- SAP Digital Manufacturing Cloud
- Microsoft Office applications with Excel
- Document management systems (eDMS)
- EMC Documentum incl. special interfaces with QUMAS, DocCompliance, First Doc, McLaren, C6
- ELO, etc.
- CAQ systems
- SAP QM
- Böhme & Weihs
- Application Life Cycle / IT Service Management Systems (ITSM)
- SAP Solution Manager
- HQ Quality Center
- BMC Remedy Action Request System
- Frontrange ITSM, etc.
- Siemens Polarion
- In-house software developments
- Facility Management Systems
Here you will find our consulting services on the subject of software validation/computer system validation (CSV).
Among other things, DHC provides support in:
- Conception of the digital validation strategy
- Automation and digitalisation of validation processes
- Central management of validation documentation
- Automated testing
Here you will find our consulting services on the topics of Digital Validation Scorecard, VxP | Validation Platform.
- Adoption of change processes
- Maintenance of the valid state
- Adaptation of validation documentation
Here you will find our consulting services on the topic of Managed Validation Services.
Learn more about the DHC consulting topics for medical technology!
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 solutions and services. These 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.
Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0
CEO and Director Sales & Marketing, DHC Switzerland
phone: +41 44 500 888 7
WEBINARS AND EVENTS
DHC & LSA Web session (in German)
SAP S/4HANA Transformation and Validation in the Life Sciences Industry
Learn everything about phases for the system transformation (system conversion) of an SAP ECC to S/4HANA with integrated validation.more
DHC web session (in German)
Integrated LIMS with QM in SAP S/4HANA
The web session gives an overview of the different QM functions in SAP and their integration into logistics.more
DHC web session (in German)
Validation of Microsoft Dynamics 365
What validation requirements arise when using Microsoft Dynamics 365 in a regulated environment.more