Expert guidance for the full lifecycle of your IVD — from transition strategy to sustainable compliance.
The transition from the IVDD to the EU IVDR marks a major change, imposing stricter standards for clinical evidence, quality management, and notified body (NB) supervision. This is crucial for retaining market access.
We can assist with this process. Our experienced regulatory affairs experts work with you to create and implement a straightforward, efficient plan for CE marking and ongoing compliance.
We start with a detailed assessment of your needs through interactive workshops and then provide hands-on support to turn your strategy into an audit-ready reality.
Lay the right foundation to de-risk your transition and save resources.
A strong regulatory strategy is crucial for a successful IVDR transition. Starting early, it aligns your technical, clinical, and commercial plans, helping to avoid costly mistakes and delays. Our service offers the complete roadmap you need.
A comprehensive review of your current technical documentation, QMS, and clinical evidence, providing a prioritized action plan.
A thorough review of your device's intended purpose to determine its proper IVDR risk class (A through D), which guides the conformity assessment pathway and level of scrutiny.
Assessing the need for new performance studies under the IVDR's stricter regulations and planning the scope of essential clinical work, which is often the most resource-intensive part.
Guidance on how to select and engage with an NB early, understanding their specific timelines and expectations to prevent delays.
You gain a clear, actionable understanding of the steps, timeline, and investment needed for IVDR compliance, enabling informed decisions and efficient resource use from the beginning.
Transform complex requirements into organized, audit-ready documentation that stands the test of time.
For IVD manufacturers, obtaining and maintaining CE marking depends on technical documentation that fully complies with Annexes II and III of the EU IVDR (2017/746). This documentation must demonstrate conformity with the core General Safety and Performance Requirements (GSPRs) in Annex I and properly reference applicable harmonized standards or Common Specifications.
We focus on transforming this complex requirement into an effective process. Whether you're updating legacy content or creating a new technical file, our expert guidance offers a clear path to documentation that is comprehensive and review-ready.
We conduct a comprehensive review of your current materials against IVDR requirements at any stage of your project. This review identifies all gaps and provides a customized, step-by-step plan to ensure compliance, making sure no critical element is overlooked.
We offer precise, actionable guidance and prompt feedback to assist you in creating your technical file. This teamwork saves you considerable time and makes sure every essential part — from risk management (ISO 14971) to performance evaluation — is thorough, well-organized, and properly supported.
We guarantee that your final documentation is carefully prepared in strict accordance with the structure and content requirements of Annexes II and III. The result is a thorough document that is specifically relevant and traceable to your device model.
Technical documentation is an evolving document. It must continuously update to reflect device changes, post-market surveillance data, and regulatory requirements. Inconsistencies often lead to significant non-conformities during NB audits.
Therefore, our support extends beyond initial compilation. We help you establish and follow a process that ensures your documentation's ongoing consistency and compliance.
Establish robust processes for sustainable compliance and proactive market surveillance.
Under the IVDR, a compliant Quality Management System is a dynamic framework that combines regulatory strategy, device lifecycle management, and ongoing improvement. When paired with strict post-market activities, it guarantees your continued compliance and product safety.
We go beyond documentation to help you achieve operational excellence. Our experts work seamlessly with your team to develop and update processes that integrate smoothly into your daily routines, transforming IVDR requirements from a simple checklist into a competitive advantage.
We develop, update, and optimize your QMS to meet the specific requirements of the IVDR, ensuring alignment with standards like ISO 13485:2016. Our focus is on creating a practical, dynamic system that effectively manages all aspects of device lifecycle control, from design and development to supplier management and corrective actions.
The IVDR significantly enhances requirements for PMS and PMPF. We offer the strategy, instructions, and customized templates you need to:
Sustainable compliance depends on company-wide understanding. We create and deliver focused training sessions to educate all key employees (from R&D to marketing) about the IVDR's impact on their roles. This fosters internal expertise and promotes a proactive culture of quality and compliance.
You acquire a QMS that not only passes audits but also enhances efficiency, along with a vigilant post-market system that proactively manages risk, informs device improvements, and seamlessly fulfills your regulatory obligations.
Contact our regulatory experts to discuss your IVD compliance needs and build a clear path forward.
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