Device
The development of medical devices is technically demanding and, at the same time, strictly regulated, as safety, performance, and clinical benefit must be demonstrated and continuously validated throughout the entire product lifecycle. The central task is the systematic demonstration of conformity with the MDR/IVDR and relevant standards so that a product may be placed on the market and used in routine clinical practice. Even in the early phases – from the initial idea through design to clinical evaluation – regulatory requirements, evidence strategy, and quality management must be planned in close coordination.
To provide targeted support to project teams in this complex environment, we offer three complementary services in the «Medical Device» sector:
Regulatory Coaching – Holistic
We provide holistic, partnership-based support for medical device projects, integrating regulatory, evidence-based, and quality-related requirements early in the development planning process to consistently prepare them for conformity assessment, submissions, and clinical use.
• Holistic, early-stage consulting for medical device projects throughout the entire development process
• Early identification and classification of regulatory, evidence-based, and quality requirements
• Strategic integration of these requirements into the planning and design of the development program
• Strengthening the interface between research, clinical practice, quality assurance, and regulation
• Utilization of QA, regulatory affairs, GLP infrastructures, clinical trial centers, and coaching to prepare for conformity assessment and submissions
Quality and Regulatory Consulting – Specific
We support clearly defined quality and regulatory work packages in medical device development, provide a quality-controlled development environment starting in 2027, further develop project-specific quality management frameworks, and create a solid foundation for submissions, audits, and partnering through structured, audit-ready documentation and process optimization.
• Handling clearly defined quality and regulatory work packages and subprojects
• Provision of a quality-controlled, regulated development environment (QMS starting in 2027)
• Establishing and further developing project-specific QM frameworks for medical devices and IVDs
• Ensuring structured, traceable, and audit-ready documentation
• Support with reviews, process optimization, and preparation for submissions, audits, and partnering
Service Facilities - Support
We combine consulting, specialized infrastructure, and appropriate testing and development environments to systematically prepare medical devices for conformity assessment and market launch throughout the entire development and evidence pathway.
• Consulting throughout the entire development and evidence pathway for medical devices
• Identification and provision of suitable infrastructure and expertise (GLP laboratories, testing centers, clinical facilities, ISO 13485 QMS)
• Strategic coordination of steps to prepare for conformity assessment and market launch