Josephine Shonaike
The ever-evolving landscape of healthcare regulations presents distinct challenges, particularly when bringing In Vitro Diagnostics to market. LFH Regulatory is your specialist partner, providing the expertise to navigate this intricate process.
Our skilled consultants offer a wide array of services, ensuring your IVDs ,meet and successfully adhere to regulatory standards.
At LFH Regulatory, we offer a variety of services aimed at facilitating the regulatory framework essential for bringing and maintaining your In Vitro Diagnostics on the market.
As a leading Medical Device Consultancy, our regulatory strategy acts as the compass for new product development and design change initiatives.
This strategy aligns the activities required to bring your product to market within agreed timelines and regions. It offers invaluable direction to your project team, identifying key regulatory components and proactive solutions to potential challenges.
We anticipate issues and concerns with regulatory authorities and stakeholders, creating a roadmap marked by key milestones.
Technical Documentation is a regulatory requirement that serves as the tangible evidence of how your IVD conforms to defined regulatory standards.
These documents must be meticulously maintained throughout your device’s life cycle.
Our team is well-equipped to assist in the creation, maintenance, and remediation of your technical files, ensuring your device remains compliant and safe for market placement.
Risk management is a critical aspect of the entire life cycle of an In Vitro Diagnostic. Our expertise is designed to assist you in creating your risk management file.
We help by crafting your risk management plan, aiding in the identification and scoring of potential hazards, and offering strategies to mitigate these risks.
Our services extend to developing your risk management report and conducting hazard analyses to ensure the sustained safety and effectiveness of your product.
Under Article 15 of the In Vitro Medical Device Regulation 2017/746, there’s a mandatory requirement for a Person Responsible for Regulatory Compliance (PRRC) with specific qualifications and experience.
Our experts possess the appropriate qualifications to support your organisation in fulfilling these PRRC responsibilities.
At LFH Regulatory, we aim to provide a comprehensive range of services, ensuring your In Vitro Diagnostics devices remain compliant.
Our diverse team boasts a wealth of experience working with medical businesses of all sizes, from innovative start-ups to international enterprises with stellar reputations. We are dedicated to guiding you through changing regulations, and facilitating your journey to success.
Contact LFH Regulatory today to discuss your unique requirements and explore how our consultancy can help bring your IVDs to market and keep them there.
At LFH Regulatory, we strive to provide a comprehensive range of services, ensuring your in vitro diagnostics devices are compliant. Our team has a wide variety of experience working with medical businesses of all sizes, from small start-up companies to international businesses with major reputations, and can support you through changing regulations.
Contact us today to discuss your requirements and learn more about how we can bring your medical devices to market.
We recognise the critical importance of your QMS to your organisation, customers, patients, and regulatory agencies.
Whether you are navigating the complex UK and European markets or expanding your reach globally, our QMS expertise is tailored to meet your specific needs.
Clinical and performance evaluations are a vital step in validating the safety and efficacy of your medical devices or IVDs.
Understanding Medical Device and In Vitro Diagnostic (IVD) regulations is complex and requires a comprehensive understanding of the entire product lifecycle.
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