LFH Regulatory is your trusted partner in navigating the complex world of medical device and IVD regulation.
We offer a comprehensive suite of services designed to empower businesses in achieving their regulatory goals.
Ensuring quality is essential in the medical device & IVD industry. Patient safety, regulatory compliance, and market success all hinge on the quality and consistency of your medical products.
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 and performance evaluations are a vital step in validating the safety and efficacy of your medical devices or IVDs.
Understanding Medical Device and In Vitro Diagnostic (IVD) regulations is complex and requires a comprehensive understanding of the entire product lifecycle.
LFH Regulatory offers expert consultancy services in key healthcare sectors, including Software as a Medical Device (SaMD), In Vitro Diagnostics (IVDs), startups, and medical device consultancy.
We provide comprehensive support to navigate regulatory challenges and ensure successful market entry across these areas.
Laura Friedl-Hirst
We work with you to build a regulatory framework to meet all compliance requirements, so you can get your products to market quickly and effectively. We offer regulatory, quality and clinical solutions for all medical devices, including In Vitro Diagnostics.
Our team has vast experience working with businesses of all sizes – from small start-ups to global manufacturers. We guide and support companies through the ever-changing regulations to ensure that each product meets the regulations and achieves accreditation. We also provide continued support throughout the lifecycle of your device, so your product not only gets to market, but stays there.
In addition to global regulatory support, we also support clients with the creation, remediation, and updating of clinical and performance evaluations. We can act as your UK Responsible Person. We also implement and maintain Quality Management Systems and deliver in-house training.
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We are a leading consultancy when it comes to regulatory framework for IVDs and Medical Devices.
LFH Regulatory is your trusted partner in navigating the complex world of medical device and In Vitro Diagnostic Regulations. Founded in 2019 by Laura Friedl-Hirst, our company has quickly grown into a dynamic team of passionate professionals.
Explore the latest insights from LFH Regulatory as we navigate the complexities of compliance in today’s rapidly changing regulatory landscape.
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 and performance evaluations are a vital step in validating the safety and efficacy of your medical devices or IVDs.
Understanding Medical Device and In Vitro Diagnostic (IVD) regulations is complex and requires a comprehensive understanding of the entire product lifecycle.
Want to stay up to date? Subscribe to our newsletter.
Simplify your path to compliance, reach out to our experts today!
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