Regulatory Strategy Support
The most efficient, compliant path to market and beyond.
We create a comprehensive regulatory plan
Bringing a medical device or IVD to market starts with a comprehensive regulatory strategy. But how to create that? Often, we see MedTech companies begin designing a product without a clear regulatory roadmap, missing out applicable standards or target countries. This may lead to misaligned clinical plans, costly redesigns, additional testing or regulatory delays in the approval process and limited market access.
These challenges are amplified for companies utilizing new technologies, software as a medical device (SaMD), or global expansion into unfamiliar regulatory territories.
Our Regulatory Strategy Support addresses these challenges early by helping you define the right regulatory strategy and know your target markets. We create a comprehensive regulatory plan outlining steps and considerations, identify gaps, and align your product, documentation, and testing with global requirements. With the right strategy, you move faster, avoid unnecessary hurdles, and stay focused on getting your product to patients safely and efficiently.
Satisfied Clients
Discover how we can help:
Regulatory and Clinical strategy meetings with Notified Bodies (Structured Dialogue)
We support you in structured dialogues with Notified Bodies to align regulatory and clinical expectations early on.
Regulatory strategy and planning (EU)
We develop your regulatory strategies, including classification, conformity routes, and documentation planning, not only for EU or US market access but also for other countries worldwide.
Regulatory strategy and planning (US)
We guide you through FDA pathways (510(k), De Novo, PMA) with strategic planning around pre-submissions, interact with the FDA, prepare your submission documentation, and submit on your behalf.
Regulatory strategy and planning (China)
We help you with NMPA registration, including coordinating local testing, clinical evaluation, and submission formatting. Our local Chinese consultants, who have deep knowledge of Chinese regulations, help reduce entry barriers and shorten timelines.
Regulatory strategy and planning (worldwide country registrations)
We manage your registration in your target countries.
Companion Diagnostics (CDx) strategy
We develop regulatory and clinical strategies for CDx devices, ensuring alignment between the drug and IVD regulatory pathways. Our support spans co-development planning, evidence generation, and agency interactions.
Market Access Strategy
We create your regulatory and clinical strategy and planning to support early and sustainable market access.
EU AI Act
We help you assess and classify AI-based medical devices under the EU AI Act and MDR/IVDR intersection. Our experts support you through development to market entry to ensure compliance with standards, AI, and medical device regulations.
To prevent loss and operational inefficiency in regulatory strategy support, companies must integrate regulatory considerations early in their product development process. This means involving regulatory experts immediately to identify potential compliance challenges before they become costly problems. Clear ownership of regulatory tasks is essential, with well-defined roles and accountability to avoid confusion and duplicated efforts.
Companies should also stay updated on ever-changing regulations to ensure their strategies remain compliant and efficient. Streamlining communication between regulatory teams and other departments helps prevent delays and misalignment, which can cause operational bottlenecks. Leveraging technology and tools to track regulatory submissions and approvals can reduce errors and speed up processes.
By partnering with Qserve, you can benefit from our expert guidance, efficient management of regulatory submissions, and strategic advice to ensure a smooth product approval process and market entry.
Couldn't find your question?
What happens if I don’t have a clear regulatory strategy early in development?
Without a defined strategy, you risk:
- Misaligned clinical and regulatory plans
- Applying the wrong conformity assessment route
- Missing out on applicable regulations and standards
- Incomplete or incorrect technical documentation
- Missing country-specific requirements
This can lead to costly redesigns, re-testing, rejected submissions, or delayed approvals.
How can Qserve support my regulatory strategy?
Qserve helps you develop comprehensive, compliant strategies that cover:
- Product classification and conformity assessment
- Regulatory pathways in the EU, US, China, and other markets
- Clinical and technical documentation planning
- Agency interactions (e.g., FDA, Notified Bodies)
- For Companion Diagnostics (CDx) and AI-based technology compliance, we work cross-functionally to align regulatory, clinical, and market access considerations from the start.
What is a structured dialogue with a Notified Body, and how can Qserve help?
A structured dialogue is a planned, early interaction with a Notified Body to align on clinical and regulatory expectations before submission. Qserve helps you prepare for these meetings to minimize surprises and optimize your regulatory position.
Can Qserve help with regulatory strategy for Companion Diagnostics (CDx)?
Yes. We provide end-to-end CDx strategy support. From co-development with pharma partners to regulatory alignment between the diagnostic and therapeutic components, including clinical evidence planning and agency engagement.
How does Qserve address regulatory challenges for AI-based medical devices?
We interpret the latest regulatory guidance for AI/ML-based SaMD and help you determine the correct software classification and intended use. We also align your regulatory strategy with the AI model lifecycle and help develop robust clinical and regulatory submission documentation.
When should I involve Qserve in my product development process?
Ideally, as early as possible. Early involvement allows us to provide regulatory support throughout the design phase, identify regulatory inputs and timelines, and plan your submissions efficiently. This will save you time and costs and reduce your time to market.