In Vitro Diagnostics

UK Based IVD Regulatory Consultancy

In the healthcare industry, precision is paramount and that begins with In Vitro Diagnostics (IVD). Europe alone registers over 500,000 types of medical devices and IVDs, a diverse spectrum that encompasses vital diagnostics like HIV blood tests, COVID-19 diagnostics, and advanced medical technologies such as blood glucose monitors for diabetics. 

Why Choose LFH Regulatory for IVD Consultancy?

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. 

Comprehensive IVD Regulatory Support

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:  

Regulatory Strategy: Charting Your Path to Success

A well-defined regulatory strategy serves as the foundation for most projects in new product development and design change. It aligns the activities necessary to bring your product to market within agreed-upon timelines and regions. This strategy provides overarching direction to your project team, defining key regulatory components and proactively identifying potential challenges and alternative pathways for development. It also anticipates issues and concerns with regulatory authorities and stakeholders, establishing key milestones. This allows us to inform you of needed changes to your strategy and increases your chances of accessing your target markets within agreed timelines   

Risk Management: Putting Patient Safety First

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.  

Technical Documentation: Evidencing Compliance

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.  

Person Responsible for Regulatory Compliance (PRRC)

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. 

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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Training
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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Taking the Next Step: Your Partner in Regulatory Success

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 for IVD Compliance  

Ensure your In Vitro Diagnostics are meeting regulatory standards today. Contact LFH Regulatory today to discuss your unique requirements and explore how our consultancy can help bring your IVD’s to market and keep them there.  

Next Steps

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.