At LFH Regulatory, we are the leading UK-based Medical Device Regulation Consultancy, dedicated to simplifying the complexities of compliance for approximately 500,000 different types of medical devices and in vitro diagnostics (IVDs) registered in Europe. From medical imaging devices to innovative pacemakers, our expertise spans the diverse spectrum of medical technologies.
Laura Friedl-Hirst, MD
In a dynamic regulatory landscape where requirements to bring medical devices to market are constantly evolving, we stand as your beacon of expertise to guide you through the intricate process.
Our seasoned consultants are equipped to address the ever-changing regulatory demands, ensuring your products meet compliance requirements.
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 the backbone of regulatory compliance. It serves as tangible evidence of your device’s adherence to defined regulatory requirements.
This documentation must be diligently maintained throughout your device’s lifecycle.
Our Medical Device Consultants play a pivotal role in creating, updating, and remediating your technical files, guaranteeing that your device is consistently compliant and safe for market placement.
Our adept team of consultants offers a comprehensive suite of services tailored to facilitate your regulatory needs.
We support you throughout the medical device lifecycle, from the initial design stages of early testing documentation to market launch and ongoing lifecycle management.
Our services encompass a wide range of crucial elements in the regulatory landscape.
Under Article 15 of the Medical Device Regulation 2017/745, it’s a necessity to appoint a Person Responsible for Regulatory Compliance (PRRC) with specific qualifications and experience.
Our consultants possess the expertise required to support your organisation in fulfilling PRRC responsibilities.
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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