All About the Medical Regulatory Process

    The medical device industry continues to make inroads in the EU and UK marketplace. Technological advances are rapidly elevating the med-tech landscape, creating exciting new opportunities for medical device manufacturers. However, before they can reap the fruits of these opportunities, it is important to gain appropriate regulatory training.
    As a brand focusing on medtech, 5AI Consulting has the knowledge and expertise to deliver exceptional services. Our consultants have made it their responsibility to help medical device manufacturers by maintaining their regulatory, quality, and market strategic needs. Our extensive experience comprises the following product classifications:

    • Medical devices
    • IVDs
    • Software as a medical device
    • Combination products
    • Companion diagnostics

    IVDR and MDR

    By complying with Regulation EU 2017/745 on medical devices, and Reputation (EU) 2017/746 on in vitro diagnostic medical devices was released on May 5th, 2017, and was mandated on May 25th, 2017. The ongoing compliance with the MDR and IVDR presents substantial challenges for medical device manufacturers.

    Our company has dedicated its experience and Knowledge to helping manufacturers throughout the product’s lifecycle. With our adept and results-focused methodologies and hands-on support to customise quality and regulatory solutions, our goal is to help manufacturers market their products within confined budgetary limitations.

    Helping You Fulfil Your Market Ambitions

    Our goal is to help medical device manufacturers at every step of their regulatory journey. We help in:

    • Product Development and Program Management
    • Setting Up Quality Management Systems
    • Strategic Guidance
    • Regulatory Submissions
    • Post-Market Compliance
    • Health Economics

    We deal with all kinds of organisations ranging from start-ups to top MNCs, by delivering robust and region-specific services to ensure market success.
    Medical Regulatory Training Services

    5AI Consultants is ISO 9001:2015 and ISO 13485:2016 certified. We pride ourselves on handling one of the most challenging aspects of medical device regulations – medical regulatory training. Our consulting team possesses the expertise to guide you through all stages of the FDA’s regulations of medical devices.

    Our consultants help manufacturers with:

    • Regulatory path determinations for medical devices, with relevant parts, including the Requests for Designation and important technical documentation used beforehand.
    • Identifying and evaluating performance data required for pre-market submissions, like pre-submissions.
    • Assisting with the FDA’s Investigational Device Exemption (IDE) and other clinical study requirements.
    • Preparing you for representing your devices at FDA and Advisory Committee Meetings.
    • Supporting you through the establishment registration and listing process.

    Our range of medical regulatory services is quite extensive and covers all crucial aspects of the process. We also remain available for any other assistance you might need in this area. For instance, we also offer help with fulfilling post-market requirements for your products, including:

    • Corrections and Removals
    • Labelling
    • Medical Device Reports
    • Device Modifications

    Are you ready to make a difference in the EU and UK marketplace? Let’s talk!

    There are many reasons why you should consider letting us help you. Our experts become your partners for the entire life cycle of your medical devices. Further, we ensure that you are legally allowed to sell your medical devices in the EU’s marketplace. Also, we customise our services to align with your marketing and regulatory objectives, ensuring the entire process becomes convenient and simple.