Whether you’re working with us to develop a sound strategy in our joint regulatory workshop (MDR & IVDR) or need a thoroughly researched, comprehensive international strategy: We ensure regulatory compliance and predictability for your product.
When developing and launching medical devices or in vitro diagnostic devices, companies regularly face complex regulatory issues:
A lack of clarity on these points leads to delays, additional costs, and rework later in the development and approval process.
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... of the Product and Claims in Accordance with Regulatory Requirements.
MDR, IVDR, FDA, and other relevant markets.
... regarding costs, timelines, and regulatory requirements.
... for each next step.
Choose the approach that best suits your current stage or product type—from an interactive regulatory strategy workshop with your team to a comprehensive, internationally focused strategy based on extensive research.
Together, we’ll develop the strategic foundations for your medical device in a structured, interactive workshop. This is an ideal way to bring the entire team up to speed and define the next steps.
Scope of Services:
Your benefit: After just one day, you’ll know exactly whether your product is a medical device, what steps you need to take, and what the financial and timeline roadmap looks like.
Right for you: If you want to quickly gain well-founded clarity on regulatory requirements and achieve internal alignment.
This three-step model combines interactive coordination in a workshop with in-depth, detailed regulatory research. It provides you with a well-founded document for your entire business case.
Scope of Services:
Your benefit: You receive well-founded regulatory documentation for your business case that minimizes potential hurdles and transparently outlines the costs and duration of the approval process.
Right for you: If you need a comprehensive, written strategy for internal and external stakeholders or parallel international approval.
For our workshops and strategies, we need documents such as a product description, information on how the product works, promotional materials/claims, and the current wording of the intended purpose in advance (if available, even in draft form). For software products, a list of inputs/outputs, interfaces, and—optionally—a description of the architecture are important. We will agree on a detailed checklist during our initial consultation.
To ensure maximum success, the decision-makers responsible for the product (executive management, product management, marketing) and technical development (project managers, developers) should be present.
Let's schedule a brief, no-obligation initial consultation to determine which model best suits your current situation, your innovative idea, and your business goals.
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