Design tailored for manufacturing
Regulatory Affairs
From Design to Commercialization
Regulatory requirements are central to the healthcare industry and are integral to the lifecycle of medical devices. From design to market launch and post-market monitoring, they represent a significant challenge for medical device manufacturers.
Attuned to your specific challenges, we support you in your regulatory processes, including drafting the technical documentation for your medical devices.
Beyond documentation, we bring our regulatory expertise to help you manage timelines, costs, and risks associated with the regulatory process for your device.
Our Support
Medical Device Evaluation and Classification
From the early stages of drafting the design brief, our teams assist in evaluating and classifying your medical device.
This step is crucial for determining the risk level and corresponding obligations. Misclassification can lead to delays or approval rejections, making expertise in this area critical.
Compliance with Applicable Standards
Our engineers, in close collaboration with our regulatory affairs team, ensure that the design of your medical device complies with applicable standards.
Choosing a design office with a specialized regulatory affairs team guarantees a compliant device with controlled timelines and costs.
Technical Documentation Preparation
Our design teams pay meticulous attention to preparing the technical documentation. This dossier compiles all the evidence required to demonstrate the safety, quality, and performance of the device. It includes clinical studies, test reports, and risk analyses.
Our regulatory affairs experts then help organize these documents to meet the expectations of authorities such as the FDA or notified bodies for CE marking in Europe.
Change Management Support
Supporting change management in medical devices is crucial to ensure that all modifications to products or processes are appropriately documented and comply with regulatory requirements.
Our teams assist in managing these updates, whether for technical documentation, CE marking, or FDA approvals.
By providing comprehensive documentation to submit to regulatory authorities, we mitigate any risks of non-compliance that could jeopardize the commercialization of the device.
Our Commitments
Comprehensive and Up-to-Date Regulatory Expertise
We are committed to providing cutting-edge expertise in regulatory affairs.
Our teams are well-versed in international requirements, such as Regulation (EU) 2017/745 (MDR), FDA regulations (21 CFR Part 820), and ISO standards, including ISO 13485. Through proactive regulatory monitoring, we stay updated on legislative developments to anticipate changes and ensure the compliance of your medical devices.
Tailored Strategy and Personalized Support
Each project is unique, and we take the time to understand your specific needs and the characteristics of your medical devices. Our recommendations are tailored to your objectives and the markets you are targeting.
We develop customized strategies to streamline the registration process while minimizing risks.
We provide customized assistance in preparing technical documentation and implementing regulatory strategies, ensuring your medical devices meet the highest standards and are market-ready.
Assistance with Technical Documentation
We support you in the creation and review of essential technical documents required for regulatory compliance.
We also ensure that these documents meet the applicable regulatory requirements.
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Offers tailored to the different stages of your project
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