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

Article 117 Notified Body Opinion Process Explained for Drug Device Combination Products

Verification and Validation for Medical Devices, A Practical Guide to V&V Testing

Medical Device Design and Development Under ISO 13485 and EU MDR

MHRA Clinical Investigations for Medical Devices, A Practical Guide for UK Manufacturers

Do MedTech Startups Need ISO 13485 Before Funding?

NHS DTAC Explained, What Digital Health and MedTech Companies Need to Know

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