Medical Technology (Medical Devices, Firmware)

Innovative and Secure!

There are a number of standards, regulations and customer requirements that determine the general market requirements and the business behaviour of companies in the medical devices industry. This gives rise to diverse compliance activities such as validation, risk management, comprehensive documentations and the implementation of transparent management systems that are approved by the standards. The regulations are notably mutifacetted and may, for example, be generated from the Medical Devices Law, the existing cGMP regulations for medical devices (Quality System Regulations, 21 CFR 820), FDA requirements, and requirements in ISO World (DIN EN ISO 9001 / EN ISO 13485:2003, IEC 62304, etc.).

Because of the competition for resources between compliance activities and innovation and production activities in the company, it is critical to develop strategies and concepts for realisation of lean solutions and utilise the synergy effects.
The company’s goal must be the ability to quickly bring approved, safe, and high quality innovative products to the market. This requires comprehensive management, compliance and IT know-how.
DHC Dr. Herterich & Consultants GmbH have supported companies in the medical devices industry with innovative IT concepts for management of GRC, IT, quality, BPM, and logistics since 1996.
As your consulting partner, we provide business process based solutions under fulfilment of regulatory requirements in the form of integrated consultancy or approaches. In 1999, DHC began developing their own software, DHC Vision, so as to offer companies a robust tool for implementation of management solutions that are conformable to the norms and standards.

Today, DHC Vision comes with the following reference solutions which can be modularly expanded or upgraded to an Integrated Management System (IMS):
• Process Manager
• Validation Manager
• Risk Manager
• QMM Manager (Quality Management Manual Manager)
• Audit Manager
• Measurement Manager
• SOP/Operating Procedure Manager
• CAPA Manager (Deviations, Complaints, OOS)
• ICS Manager (Internal Control System)
• Change Manager
• Project Manager
• Enterprise Architecture Manager
• Information Security Manager

As your Consulting Partner, we also support you in the conceptual development of these themes.

In addition, we offer consultancy services for:
• Governance, Risk & Compliance Management
• Validation (Computer Systems, Processes, Products, Facilities)
• ERP Selection
• SAP Implementation and Optimisation
• Optimisation of Logistics Processes in SAP
• Optimisation of Quality Processes in SAP
• Complaints Management
• Supplier Assessment
• Test Equipment Management …