Medical Device Regulatory Consulting and Services
Simplifying Medical Device Compliance with Tailored Solutions
Lumis provides medical device regulatory consulting and services throughout your product’s lifecycle.
We help you obtain medical device CE marking and maintain regulatory compliance. Each device comes with its own regulatory challenges, but our experts are here to guide you through this complex landscape to accelerate your product’s development.
We’re a boutique, agile consultancy, ideal for small and medium-sized companies. Our medical device regulatory consulting services are tailored to your needs – whether it’s devising regulatory strategies, writing technical documents, managing entire submissions, or providing ad-hoc support. We combine state-of-the-art project management tools with deep medical device regulatory expertise to ensure timely, cost-effective, and high-quality results.
With over 10 years of experience, Lumis has built a reputation for excellent customer service and expertise, repeatedly becoming a trusted partner for medical device companies. Contact us today and learn how we can be your trusted regulatory partner.
Unsure how to approach the EU regulatory pathway? We’re here to help.
Our 3E Advantage: Expertise. Efficiency. Expedited.
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Leverage Expertise
Leverage our regulatory & project management expertise for cost-effective delivery.
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Delegate Work
Focus on scientific innovation and leave the complex regulatory burden to us.
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Accelerate Development
Harness our proven strategies to navigate regulations and fast-track market entry.
Unsure how to approach the EU regulatory pathway? We’re here to help.
Medical Device Regulatory Consulting and Services
Our agile team is a perfect fit for small and medium-sized device companies. We tailor our medical device regulatory consulting services and other solutions to your needs. With our expertise in EU medical device regulations we support your device throughout its lifecycle, helping you quickly secure medical device CE marking and maintain regulatory compliance.
Development
- Medical Device Regulatory Strategy
Our expertise in medical device development and EU medical device regulations can streamline your path to market. We help classify your product, identify applicable regulations, and create a roadmap tailored to your product and company objectives.
- Early Regulatory Interactions (EU, UK Innovation Office)
There are channels for regulatory interactions which are particularly useful for innovative technologies. We help you identify and prepare for suitable initiatives, and coordinate the entire process.
CE Marking
- Technical file writing
We compile technical files for any device class in compliance with the Medical Devices Regulation (EU) 2017/745 and your quality management system. We advise on organising your technical documentation, write your technical file or sections of it (e.g. risk management), and review your file against the applicable requirements.
- QMS design and development
Whether it’s a gap analysis, training, SOP writing, or audit preparation – Lumis simplifies your path to ISO 13485 certification.
- Notified Body/ UK Approved Body selection
We assess your company and product needs, identifying the most suitable notified body according to their designated scope and other variables. We also support you throughout any negotiations.
- Clinical evaluation report & performance evaluation – plans and reports
Our clinical development background and regulatory writing expertise allows us to compile high-quality, compliant Clinical Evaluation Reports (CERs). We offer tailored support, whether it’s conducting a literature search, providing ad-hoc consulting, or writing the entire report.
- Clinical investigation submissions
Navigating clinical investigation applications and country-specific requirements can be complex. Whether you need support with document preparation or submission management, we’re here to assist.
Post-Market
- Post-market clinical follow-up
Leverage our clinical operations expertise to effectively design and manage post-market clinical follow-ups (PMCFs). PMCF designs vary greatly by objective, whether they’re registries, surveys, or post-market clinical studies (Art. 74, MDR).
Lumis can help you design a PMCF, find the right vendors and prepare regulatory documents like PMCF plans and evaluation reports. We also can prepare study documentation (e.g. protocols, consent forms). and manage regulatory and ethics submissions (Article 74, MDR), considering country-specific requirements.
Trusted by
- Zilia Inc, September 2024Lumis’ expertise in medical device regulations and clinical affairs proved highly effective for our project. Not only did we obtain swift approvals with minimal queries but the Lumis team maintained regular communication – ensuring we had full transparency on the project’s progress.
Latest news & blog articles
Regulatory Pathways for Medical Device Clinical Trials
This is a comprehensive review of the process, pitfalls, and procedures to get study approval for medical device clinical trials. We look into the future and unpack the present, in terms of European medical device regulation and the local regulatory landscape. Along with the intricacies of EU MDR 2017/745 medical device regulations, we provide an important summary of medical device study classifications and the corresponding submission pathways.
Regulatory Pathways for Medical Device Clinical TrialsRead more
Regulatory Pathways for Medical Device Clinical Trials
This is a comprehensive review of the process, pitfalls, and procedures to get study approval for medical device clinical trials. We look into the future and unpack the present, in terms of European medical device regulation and the local regulatory landscape. Along with the intricacies of EU MDR 2017/745 medical device regulations, we provide an important summary of medical device study classifications and the corresponding submission pathways.
Regulatory Pathways for Medical Device Clinical TrialsRead more
Speak with a medical device expert and talk through your options!
