Regulatory Compliance and Risk Management
Fixed Price: €27,000 (net)
This 4-week engagement includes four consultation meetings and a final compliance report. Two senior consultants and one junior consultant will ensure your business meets all regulatory requirements.
Our Regulatory Compliance and Risk Management service is designed to help your business navigate the complex regulatory landscape of the German healthcare market. With our comprehensive analysis, we ensure that your operations meet all necessary legal requirements and mitigate potential risks, allowing you to focus on growth and innovation. This package includes a thorough review of relevant regulations, a compliance gap analysis, risk assessment, and the development of a risk mitigation plan. Delivered at a fixed fee, this service guarantees cost transparency while safeguarding your business from regulatory pitfalls.
01
Objective
​Ensure full regulatory compliance and proactively manage risks in order to facilitate smooth product registration, mitigate market-entry barriers, and reduce operational and reputational risks when entering or expanding in the German healthcare market.
Activities
-
Regulatory Framework Analysis: Review of all relevant German and EU healthcare regulations, MDR/IVDR guidelines, and national compliance requirements.
-
Risk Identification and Assessment: Systematic evaluation of regulatory, operational, and financial risks specific to your product and market entry.
-
Compliance Gap Analysis: Identification of compliance gaps in your current documentation, processes, and product features.
-
Risk Mitigation Planning: Development of strategies to address regulatory challenges and minimize risk exposure throughout the product lifecycle.
02
Deliverables
-
Regulatory Compliance Report: A structured overview of applicable regulations, compliance gaps, and tailored recommendations for meeting requirements.
-
Risk Assessment & Mitigation Plan: A practical framework outlining identified risks, their potential impact, and prioritized measures to address them.
-
Compliance Roadmap: A step-by-step plan guiding you through the regulatory approval and compliance process, ensuring clarity and predictability.