LFH Regulatory Limited

medical devices

About

LFH Regulatory Limited is a UK-based consultancy focused on regulatory, quality, and clinical compliance for medical devices and in vitro diagnostics (IVDs). Founded in 2019 by Laura Friedl-Hirst and located in West Yorkshire, the company assists a diverse range of clients, from startups to large global organizations, in navigating the regulatory landscape for medical devices, including software as a medical device (SaMD) and implantables. The company provides a wide array of services, such as quality management system implementation, technical file creation, regulatory strategy development, risk management, and clinical evaluation report writing. LFH Regulatory also acts as the UK Responsible Person for regulatory compliance and supports global device registrations, including CE/UKCA marking and FDA approval. Their team has extensive experience across all medical device classes, ensuring clients receive tailored support throughout the product lifecycle, from design to post-market activities. LFH Regulatory is committed to building long-term relationships with clients by simplifying regulatory processes and addressing their unique business needs.

Technologies

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Keywords

medical equipment manufacturing regulatory project management post-market surveillance uk mdr clinical evaluation regulatory updates product lifecycle biocompatibility clinical data regulatory remediation medical device registration regulatory submissions biological evaluation services clinical and performance evaluations risk assessment medical devices risk management regulatory affairs regulatory services mdsap regulatory support medical device regulation regulatory training regulatory guidance regulatory consulting regulatory process support b2b other scientific and technical consulting services qms implementation biological evaluation

Location

Leeds, England, United Kingdom

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