Medical Device Consultancy

UK-Based Medical Device Regulatory Consultancy

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.  

Why Choose LFH Regulatory for Medical Device Consultancy?

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  

Comprehensive Regulatory Support

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:  

Regulatory Strategy: Navigating the Regulatory 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.  

Risk Management: Safeguarding Your Product's Journey

Comprehensive risk management is essential at all stages of a medical device’s lifecycle. Our consultancy expertise works with you towards drafting your risk management file. We assist in formulating your risk management plan, identifying, and scoring potential hazards, and recommending risk mitigation strategies. Our involvement extends to developing your risk management report and conducting hazard analysis, ensuring the continued safety of your product.

Technical Documentation: Evidencing Compliance

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. 

Person Responsible for Regulatory Compliance (PRRC): Your Compliance Partner

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.  

Explore Our Supporting Services

In addition to our core consultancy services, LFH Regulatory offers an array of supporting services to meet the diverse needs of our clients. Our comprehensive suite of services includes: 

Medical Device Software
We specialise in navigating the unique challenges of medical device software, ensuring compliance and safety in this increasingly vital field. From data security to user interface design, we are your partners in ensuring that software-driven devices meet regulatory standards.
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UK Responsible Person
For manufacturers located outside the UK, we serve as your trusted UK Responsible Person, facilitating compliance with UK regulations. Our expertise in UK MDR 2002 ensures that your devices can access the UK market efficiently and effectively.
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Global Registrations
We streamline the complex process of global registrations, ensuring your products can reach international markets. From the EU to the USA and beyond, we manage the intricacies of diverse regulatory requirements.
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Empower your team with regulatory expertise through our comprehensive training programs. Our training covers all aspects of medical device regulations, ensuring your team is well-equipped to navigate the ever-changing regulatory landscape.
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Unlock the Power of Medical Device Consultancy

At LFH Regulatory Ltd, our medical device consultants bring extensive experience and regulatory knowledge to the table. We collaborate with a diverse array of clients, establishing connections with global regulatory bodies for efficient regulatory approvals. Contact us today and explore how our consultancy can help you successfully navigate the intricate world of medical device regulations.