Strategic Planning for Regulatory Affairs and Quality Management – Forward Thinking. Structured. Successful.
In medical technology, it is not only the product that determines market success, but also how well Regulatory Affairs (RA) and Quality Management (QM) are strategically planned and integrated with other departments. I can help you to make your RA and QM activities not only compliant, but also future-oriented, efficient and marketable.
My RA/QM strategic planning services include
Regulatory roadmaps: Development of clear strategies for international market approvals (MDR, IVDR, FDA, UKCA, etc.) – aligned with your product strategy and business objectives.
QM Strategy Development: Establishment or further development of a scalable and audit-proof quality management system according to ISO 13485 that grows with your company.
Synergies between RA & QM: Dovetailing regulatory and quality-related processes to work efficiently and holistically, in close collaboration with other departments.
Risk-based planning: Integrate risk management (e.g. ISO 14971) into the strategic direction of your products and processes
Scaling & Internationalization: Advice on regulatory and quality-related expansion into new markets.
Change & Lifecycle Management: Strategies for the regulatory and quality-driven introduction of new products, changes, or product discontinuations.
Audit & Compliance Preparation: Early strategic planning for inspections and certifications – stress-free and with lasting success.
Why a well-thought-out RA/QM strategy is critical
Accelerate time to market with clear regulatory structures – Maintain quality as product or process complexity increases.
Minimize risk, questions and delays.
Ensure compliance with current and future regulations.
Increased efficiency through coordinated processes and intelligent prioritization.
I bring not only technical and regulatory expertise, but also strategic thinking and practical experience. Together, we will develop an RA/QM strategy that not only meets the requirements, but also strengthens and future-proofs your organization.
Rethink Regulatory Affairs and Quality Management – strategically, networked and forward-looking.