Quality Management

Quality management is particularly essential for the development of medical devices. Often, however, one faces a huge mountain of countless different requirements from the regulations and general standards of FDA, CE, EU-MDR, ISO, ASTM, etc. Where to start for the new project? Which steps and documents are crucial in the beginning? Which ones will become relevant later?

With the experience of numerous successful certifications of medical devices according to FDA and CE standards, we support and advise teams and projects on quality management in product development and innovation.

Together with Q&R experts either from your team or from our network, we define the right strategy and implementation of a pragmatic quality management system. In particular, the communication of terminologies and requirements between all stakeholders is crucial in order to make targeted decisions and develop successful strategies.

Core topics in quality management

Quality-Management-System (QMS)
ISO 13485
21 CFR part 820
Development documentation
Design History File (DHF)
Device Master Record (DMR)
Requirements management
Risk management and hazard analysis
Design change management
Design Verification and Validation
Audit preparation and monitoring
FDA 510(k), Pre-Sub, PMA preparations
CE Certification and EU MDR

Project Management

Business-Case Planning

Networking & Communication

Innovation

International Cooperation

Leadership

R&D

Process Optimization / LEAN

Product Development

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