Helping You Succeed On Your Medical Device Development Journey
The iuvo Lumino Advisors team specializes in providing comprehensive medical device consulting services to support your product development journey. Lumino brings decades of experience to provide critical advisement and support for your device development program.
Our deep understanding of the necessary clinical and regulatory requirements help us ensure we develop the best strategies to accelerate timelines and reduce development program risk. Our team of experienced professionals is committed to helping you navigate the complexities of medical device development with confidence and achieve your business goals.
Expert Medical Device Consulting: Driving Insights and Innovation
We understand the critical role that consulting plays in guiding successful medical device development. The Lumino team will act as an extension of your team, providing a broad variety of support from management of preclinical testing and preparation of regulatory submissions, to serving as your interface with the FDA. We have the necessary insights and support at every stage of your project – from concept to commercialization.
Customized Solutions for Your Medical Device Consulting Needs
Every medical device project is unique. That’s why we offer customized consulting solutions tailored to your specific needs. Our team will work closely with you to understand your challenges, objectives, and timeline, and provide customized consulting services. We leverage our expertise and industry knowledge to deliver practical solutions that drive innovation, compliance, and business success.
Regulatory Strategy and Compliance
Navigating the complex regulatory landscape is a key aspect of medical device development. Our expert consultants have in-depth knowledge of global regulations, including FDA, ISO, CE and EU-MDR requirements. We can assist you in developing effective regulatory strategies, preparing regulatory submissions, and ensuring compliance with the applicable standards. With our guidance, you can navigate the regulatory processes smoothly and efficiently, saving time and resources while meeting the necessary requirements.
The EU MDR is a set of regulations that governs the production and distribution of medical devices in Europe. Lumino has extensive experience in supporting companies bringing their products into compliance including preparing Restricted Substance assessments, preparing biological safety assessment reports, and gap assessments – elements necessary for compliance to MDR.
Quality Management Systems (QMS) Development
Establishing robust Quality Management Systems is essential for ensuring product quality and compliance with regulatory standards. Our consultants can help you develop and implement effective QMS tailored to your organization’s needs. From designing standard operating procedures to conducting internal audits and facilitating CAPA (Corrective and Preventive Actions) processes, we support you in achieving a culture of quality excellence and continuous improvement.
Biocompatibility Strategy Development (Biological Evaluation Plan)
It is a regulatory expectation that a Sponsor prepare a biological evaluation plan for their new medical device, or changes to their existing medical device, within a risk management process prior to the initiation of any testing. This plan considers the nature and duration of contact to the body, the materials and manufacturing processes, existing toxicology/safety data, previous clinical use, and the relevant biological endpoints of concern. Lumino has the knowledge, expertise, and extensive experience in building regulatory acceptable evaluation strategies that identify the necessary testing or assessments that adequately address any areas of potential biological risk.
Product Development Support
Our medical device consultants provide valuable guidance throughout the product development lifecycle. From concept development and design control to verification and validation, we help you establish efficient processes and best practices. Our expertise in human factors engineering, usability testing, and design for manufacturability ensures that your medical device meets user needs, performs reliably, and can be manufactured efficiently.
Lumino is experienced in working with risk management, design control, and product development processes. We can participate informally or formally as a member of your project team, ensuring that preclinical regulatory expectations and documentation are met and that the preclinical program adequately supports the safe use of your device.
Material Selection and Chemical Characterization Strategy
Selection of materials is a key early step in developing a medical device, and smart choices can minimize risk and accelerate the product development process. Lumino can consult with your product development team to ensure the best material selection. When it is time to chemically characterize your new device or support changes to your existing device, our experts can help you design and document your testing strategy for internal use or for regulatory approval.
Biological Safety Assessment Report (BSAR)
Following the expectations of 10993-1:2018 and specific regulatory body requirements and after the biocompatibility testing has been completed, Lumino can assess whether the biological risk has been adequately addressed through the creation of a biological safety assessment report or BSAR. The BSAR will be completed by integrating the material and chemical characterization data, a critical evaluation of the safety testing data, relevant literature data, and clinical evaluation data into a comprehensive summary document supporting the safety of your medical device.
Gap Assessments Against Regulatory Standards
Gap assessments of dated standards and legacy test reports against the current standards, such as the 10993 series, is an important part of maintaining your quality system, evaluating the quality of the data set used for biological risk assessment, and ultimately the overall safety of the device. Lumino can complete gap assessments of your legacy documents to current standards, meeting your internal quality requirements as well as external regulatory expectations.
Literature Search/Literature Review
An essential part of developing a biocompatibility evaluation strategy and assessing the overall biological safety of your medical device is understanding the history of the device and the materials of composition. Lumino is skilled at conducting relevant literature searches and critically reviewing the literature to support the overall safety of your medical device.
Chemical/Material Toxicological Assessment
A toxicological assessment evaluates the potential for toxicity of individual chemicals or materials in a medical device or those identified from the chemical characterization of your device (e.g., extractables and leachables testing). Such assessments may be used for material selection, supporting product specifications, and other general safety issues. In performing these assessments, Lumino can take into account many parameters including the route and duration of exposure, usage of the device, and likelihood of exposure.
Lumino has decades of experience monitoring studies for technical competence as well as GLP compliance. We can design, place, and oversee your studies and manage any issues that might arise.
Regulatory Document Preparation/Health Authority Interaction
At Lumino Advisors, we have prepared numerous Preclinical Regulatory documents, including those that support pre-submission meetings and formal filings (e.g., IDE, 510(k), PMA). We participate regularly in interactions with FDA, Notified Bodies, and other Health Authorities. Applying our experience as both a previous sponsor and consultant, we know how to present and defend the data to ensure your success.
The preclinical development of combination products requires an understanding of the stringent medical device biocompatibility requirements as well as addressing the regulatory expectations for nonclinical pharmaceutical development. Lumino is experienced in product development pathways and therefore can readily assist in the design and execution of a nonclinical plan to meet regulatory expectations, support clinical development, and ensure the biological safety of your combination product.
Why Choose iuvo for Medical Device Consulting?
As your partner for medical device consulting, you benefit from our expertise, client-centric approach, and commitment to excellence. We have a proven track record of helping clients navigate the complexities of medical device development and achieve regulatory compliance. Our focus on collaboration, integrity, and delivering actionable insights sets iuvo’s Lumino Advisors apart as a trusted consulting partner in the medical device industry.
Contact Us Today for Comprehensive Medical Device Consulting
Our experienced team is ready to assist you in overcoming challenges, meeting regulatory expectations, speeding time to market, and driving business success. Contact us today to discuss your project and discover how our expertise in medical device consulting can benefit your organization.