Industry Expertise for
Medical Technology

DHC consulting solutions and tools for SAP Life Sciences, GxP Compliance (CSV) and Quality Management with SAP

Challenges in the
Medical Technology Industry

MDR Pressure, Audits and Uncertain Approval Processes

Increasing requirements from the MDR, bottlenecks at Notified Bodies and growing inspection pressure delay approvals and tie up resources. Many companies struggle to remain audit-ready at all times while not slowing down innovation cycles.

UDI, Data Chaos and Lack of End-to-End Traceability

UDI requirements, inconsistent master data and fragmented system landscapes impede end-to-end traceability. A lack of transparency across data and processes leads to high manual effort, increased error risk and uncertainty in regulatory reporting.

SAP S/4HANA Transformation Under Compliance Constraints

S/4HANA transformations, digitalization and new technologies must be implemented under strict regulatory requirements. Many companies face the challenge of modernizing systems without jeopardizing validation, IT compliance and ongoing operations.

Medical Technology

IT Innovation and Regulatory Compliance for Medical Device Manufacturers

The medical technology industry faces the challenge of balancing innovation, product quality and economic efficiency with stringent regulatory requirements. In particular, the EU Medical Device Regulation (MDR), international approval requirements and growing documentation obligations increase complexity along the entire product lifecycle. At the same time, digitalization, automation, cloud technologies and AI are driving the transformation of processes and IT systems at a rapid pace. Digital systems control central processes – from development through production and supply chain to post-market surveillance and vigilance. Topics such as regulatory compliance, traceability, Unique Device Identification (UDI) and validation (CSV) are business-critical to ensure product quality, patient safety and audit readiness. DHC supports medical technology companies in effectively connecting transformation and regulatory requirements. We modernize system landscapes, integrate data and processes, and ensure efficient and sustainable implementation of regulatory requirements. We combine deep industry and process expertise with knowledge in SAP Life Sciences, regulatory IT compliance and Quality Management with SAP. This is how we create seamless, harmonized end-to-end processes and embed regulatory assurance sustainably – as a foundation for efficient operations, transparency and sustainable growth in a dynamic market environment.

Medical Technology

DHC Consulting Solutions and Tools

Integrated SAP S/4HANA Transformation & Validation

The transformation to SAP S/4HANA is a key step for medical technology companies in modernizing their IT landscape. At the same time, regulatory requirements must be consistently addressed and validated – without slowing down the transformation.

Whether a new implementation or a migration from SAP ERP to SAP S/4HANA: DHC supports you in executing your integrated SAP S/4HANA transformation and validation safely and efficiently. We combine technological transformation with regulatory expertise, creating the foundation for stable, integrated and auditable processes.

Our services:

Strategy and roadmap for S/4HANA transformations in regulated environments
New implementation of SAP S/4HANA
Selection and execution of suitable transformation approaches (Brownfield, Greenfield, Selective Data Transition)
Planning and execution of integrated transformation and validation strategies for SAP S/4HANA
Data migration and system integration under compliance requirements
Support for cloud transformations (e.g. RISE with SAP)

→ Learn more about SAP S/4HANA Transformation

IT Compliance and Software Validation (SAP & Non-SAP)

Computer system validation is a central building block for ensuring product quality, patient safety and regulatory compliance. At the same time, increasing digitalization raises the demands on the efficiency and sustainability of validation processes.

Based on more than 30 years of industry experience, DHC supports you in implementing IT compliance and validation in a practical, risk-based and efficient manner – for SAP and non-SAP systems alike.

Our services:

Development and optimization of CSV and CSA (Computer Software Assurance) approaches
Risk-based validation of SAP and non-SAP systems
Creation and maintenance of validation documentation along the system lifecycle
Support during audits and inspections (e.g. FDA, EMA)
Remediation measures and sustainable anchoring of compliance structures

→ Learn more about Computer System Validation

Digitalization of Validation (DHC Smart Validation Accelerator)

Increasing system complexity and growing regulatory requirements demand new approaches to make validation efforts more efficient. Standardized, digital solutions offer significant potential in this area.

The DHC Smart Validation Accelerator is an innovative digital validation platform for regulated companies. Through the use of artificial intelligence (AI) and full integration into the SAP ecosystem – particularly as a solution extension to SAP Cloud ALM and in combination with test automation – it significantly increases the efficiency of your validation processes.

Our services:

Digitalization and automation of validation processes
Use of standardized templates and best practices
Acceleration of testing and documentation processes
Reduction of manual effort and error sources
Integration into existing system and process landscapes
Implementation of the proprietary validated DHC software solution for digitalization & automation of your validation processes

→ Learn more about the DHC Smart Validation Accelerator

Data Integrity & Audit Trail

Ensuring data integrity is a central prerequisite for GxP compliance, audit readiness and informed decision-making in regulated environments. At the same time, many companies face the challenge of digitizing legacy, partly paper-based processes and transitioning them into integrated system landscapes.

DHC supports you in sustainably ensuring data integrity and efficiently digitizing regulatory-relevant processes. We combine regulatory requirements with technological expertise, creating the foundation for transparent, consistent and auditable data along the entire product lifecycle.

Our services:

Conducting data integrity assessments (e.g. according to ALCOA+ principles)
Identification and evaluation of risks in data flows and interfaces
Digitalization and standardization of paper-based and manual processes
Design and implementation of integrated data and system landscapes
Establishing sustainable governance structures for data integrity

→ Learn more about Data Integrity

Audit Readiness & Inspektionssicherheit

Regulatory inspections regularly pose major challenges for medical technology companies. It is all the more important to maintain audit readiness at all times and respond to inspections in a prepared manner.

DHC supports you in systematically building and sustainably embedding audit readiness and inspection preparedness. We help you identify potential weaknesses early, address them in a targeted manner and optimally prepare your organization for audits and inspections.

Our services:

Conducting mock audits and inspection preparations
Identification and evaluation of compliance gaps (gap assessments)
Support during FDA and EMA inspections
Development and implementation of remediation measures
Establishing sustainable structures for continuous audit readiness

→ Learn more about Audit Readiness & Inspection Preparedness

Quality Management with SAP (CAQ / eQMS)

Integrated quality management is essential for efficiently meeting regulatory requirements while ensuring stable, transparent processes. In many companies, the challenge lies in consistently and seamlessly mapping QM processes within their systems.

DHC supports you in holistically designing your quality management with SAP and optimally integrating it into your system landscape.

Our services: