Expert guidance for the full lifecycle of your medical device — from transition strategy to sustainable compliance.
The transition from the MDD/AIMDD to the EU MDR marks a major shift, introducing stricter expectations for clinical evidence, technical documentation, quality management, and notified body (NB) oversight. These changes are critical to maintaining CE marking and uninterrupted 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 MDR 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 essential for a successful MDR transition. Starting early aligns your technical, clinical, and commercial plans, helping you avoid costly rework, delays, and unexpected notified body findings. Our service provides a clear roadmap tailored to your device portfolio and timelines.
A structured review of your current technical documentation, QMS, and clinical evidence against MDR requirements — resulting in a prioritized, practical action plan.
A thorough review of intended purpose, indications, and claims to confirm MDR classification (Class I, IIa, IIb, III) and identify implications for conformity assessment, NB involvement, and clinical requirements.
Assessment of clinical evidence gaps under MDR and development of a plan for clinical evaluation, equivalence justification (where applicable), and the need for clinical investigation and/or PMCF activities.
Guidance on how to select and engage with an NB early, understand their expectations and review timelines, and prepare for efficient submission and audit interactions.
You gain a clear, actionable understanding of the steps, timeline, and investment required for MDR compliance — enabling informed decisions and efficient resource allocation from day one.
Transform complex requirements into organized, audit-ready documentation that stands the test of time.
For medical device manufacturers, obtaining and maintaining CE marking depends on technical documentation that fully complies with Annexes II and III of the EU MDR (2017/745). This documentation must demonstrate conformity with the General Safety and Performance Requirements (GSPRs) in Annex I and appropriately reference applicable harmonized standards and guidance.
We focus on turning these requirements into an efficient documentation process. Whether you're updating legacy files or building a new technical file, our guidance provides a clear path to documentation that is complete, consistent, and review-ready.
We conduct a detailed review of your current materials against MDR requirements at any stage of your project. This identifies gaps and delivers a step-by-step plan to ensure compliance — so no critical element is missed.
We provide precise, actionable guidance and rapid feedback to help you build your technical file efficiently. This collaborative approach saves time and ensures every essential section — from risk management (ISO 14971) to usability (IEC 62366-1) and clinical evaluation — is robust, coherent, and traceable.
We ensure your final documentation follows the structure and content expectations of Annexes II and III, with clear traceability to your device configuration, claims, and verification/validation evidence.
Technical documentation is a living system. It must continuously reflect design changes, supplier updates, PMS data, and regulatory expectations. Inconsistencies frequently trigger major nonconformities during NB reviews and audits.
Our support extends beyond initial compilation — helping you establish a sustainable process to keep your documentation consistent, current, and audit-ready.
Establish robust processes for sustainable compliance and proactive market surveillance.
Under the MDR, a compliant QMS is a dynamic framework that connects regulatory strategy, lifecycle management, and continuous improvement. When paired with strong post-market surveillance, it protects patient safety and helps maintain CE marking over time.
We go beyond documentation to support operational excellence. Our experts work seamlessly with your team to develop and embed processes into day-to-day operations — turning MDR compliance from a checklist into a competitive advantage.
We develop, update, and optimize your QMS to align with MDR requirements and standards such as ISO 13485:2016. The focus is a practical, scalable system that covers design and development controls, supplier management, CAPA, change control, and lifecycle governance.
The MDR strengthens PMS and PMCF expectations. We provide strategy, instructions, and tailored templates to help you:
Sustainable compliance requires company-wide understanding. We design and deliver focused training for key functions (R&D, QA/RA, clinical, operations, marketing) to clarify MDR impact by role — building internal capability and a proactive culture of quality.
You gain a QMS that not only passes audits but also improves efficiency — together with a post-market system that proactively manages risk, informs product improvements, and consistently fulfills MDR obligations.
Contact our regulatory experts to discuss your medical device compliance needs and build a clear path forward.
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