Regulatory

The evolving regulatory landscape, including the Medical Device Regulation 2017/745, makes bringing medical devices to market challenging.

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Quality

Ensuring quality is essential in the medical device industry. Patient safety, regulatory compliance, and market success all hinge on the quality and consistency of your medical products.

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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

Clinical and performance evaluations are a vital step in validating the safety and efficacy of your medical devices or IVDs.

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Global Registrations

LFH Regulatory provides global registration services to help medical device and In Vitro Diagnostics manufacturers navigate international compliance and market access.

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We can help with everything from feasibility assessment to effective lifecycle management, as well as integrating a robust quality management system into your business operations.

Authorised Representative

LFH Regulatory offers UK Responsible Person and EU Authorised Representative services to ensure compliance with UK MDR 2002 and EU regulations for medical devices.

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Training

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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We can help with everything from feasibility assessment to effective lifecycle management, as well as integrating a robust quality management system into your business operations.

News & Articles

Implementing ISO 13485: Building a Software-Focused Quality Management System for Medical Devices

Spotlight on Morgan Malone, Business Development Manager

Clinical Evidence for Medical Devices: How to Perform an Effective Literature Search

Predicate Puzzle: Finding the Right Device for a 510(k) Submission

AI in Medical Devices: Post-Market Surveillance and FDA Guidance

IEC 62304 Compliance Checklist for Medical Device Software Teams

Regulatory

Technical File

Risk Management

Biological Evaluation

Regulatory Strategy / Market Access

Regulatory Intelligence (RI) Services

Quality

QMS implementation including ISO 13485 & MDSAP

Clinical

Clinical Evaluation

Performance Evaluation

Global Registrations

Global registration services

Authorised Representative

UK Responsible Person Services

EU Authorised Representatives

Training

Training Solutions

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Regulatory

Quality

Clinical

Authorised Representative

Global Registrations

Training