Integrated Management Systems in Medical Technology – Managing Complexity, Leveraging Synergies
In medical technology, quality management, information security, product safety, and regulatory requirements come together – often in separate systems. An integrated management system (IMS) brings these areas together efficiently, reduces redundancies and creates transparency. I can help you to network your systems and set them up in a consistent way – clearly structured, compliant and future-proof.
My services in the area of Integrated Management Systems (IMS) include
Design & Development of IMS: Development of customized, integrated management systems that combine ISO 13485, ISO 9001, ISO 27001, ISO 14971, other management standards and regulatory requirements such as MDR, IVDR and others.
Process Harmonization: Merging parallel quality management, information security, risk management, and compliance processes into an efficient overall system.
System Integration: Integration with existing tools such as eQMS, ALM/PLM, ERP or document management systems for smooth processes.
Documentation & Structure: Create clear, concise documentation with a consistent, cross-standard structure.
Training & Change Management: Support the implementation of integrated systems through targeted employee training and adoption.
Audit Preparation & Support: Preparation for combined audits and support during the certification process for integrated management systems.
Why an Integrated Management System?
More efficiency, less effort: Common processes and structures reduce duplication and create room for innovation.
Better overview: A centralized system creates clarity – internally and with regulators, customers and partners.
Leverage synergies: Interfaces between quality, safety, environment, and compliance are streamlined.
Future-proof: An integrated approach makes your company flexible for new requirements and growth.
Economic advantage: Less bureaucracy, more impact
I also support you strategically – with a deep understanding of the regulatory and organizational requirements in the medical device industry. Together, we design a management system that strengthens your processes, reduces your risks, and ensures your competitiveness.
Transform complex requirements into a clear system that is efficient, integrated and effective.