LFH Regulatory

Regulation
made simple

LFH Regulatory is your trusted partner in navigating the complex world of medical device and IVD regulation.

Watch our video

Get in touch for a free consultation

what we do

LFH Regulatory Services

We offer a comprehensive suite of services designed to empower businesses in achieving their regulatory goals.

Regulatory

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

Learn more

Quality

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.

Learn more

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.

Learn more

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.

Learn more

Global Registrations

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

Learn more

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.

Training

Understanding Medical Device and In Vitro Diagnostic (IVD) regulations is complex and requires a comprehensive understanding of the entire product lifecycle.

Learn more

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.

Sectors

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.

Medical Device Consultancy

LFH Regulatory, the UK’s leading medical device regulation consultancy, simplifies compliance for medical devices and IVDs.

We offer expert guidance and support across the entire product lifecycle to ensure successful market entry.

Software as a Medical Device

LFH Regulatory provides expert consultancy for Software as a Medical Device (SaMD), guiding you through regulatory challenges to bring your innovative solutions to market.

We offer strategic guidance and compliance support to ensure your software meets industry standards and achieves commercial success.

In Vitro
Diagnostics

Navigating healthcare regulations for In Vitro Diagnostics (IVDs) can be challenging. LFH Regulatory specialises in guiding you through this complex process.

Our expert consultants provide comprehensive services to ensure your IVDs meet regulatory standards.

Start-Ups

LFH Regulatory offers tailored consultancy services for healthcare startups, guiding you through regulatory challenges and accelerating your path to market.

Our expert team provides strategic guidance and compliance support to ensure your products meet industry standards and achieve success.

About Us

Creating Regulatory Framework for IVDs and Medical Devices

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.

We Are the Experts!

We are a leading consultancy when it comes to regulatory framework for IVDs and Medical Devices.

What Do They Say About Us?

Here’s what our valued clients have shared about their experiences working with us.

Colete Walker

Apis Assay Technologies Ltd.

During the past few months, significant changes to the IVD regulatory pathway required expert advice, which Laura and her team provided. Their wealth of knowledge was extremely valuable, supplying services like tailored SOPs, technical files, advice, and research. LFH also created a custom training program for senior staff, which was well received and useful. The LFH team is positive, professional, and approachable, resulting in a friendly and trusting relationship.

Phil Hughes

UnifAI Technology

LFH Regulatory Limited has been instrumental in supporting UnifAI Technology to implement the necessary processes and procedures required for introducing medical devices to the market. LFH has been approachable, available and efficient in the execution of this project, and continue to be a valued partner of UnifAI Technology.

Fionnuala Patterson

FPDX Consulting

LFH regulatory provide us with dedicated quality management support for our IVD medical device. On initial engagement they took time to understand our product and company in order to be able to support us fully and effectively. We find them to be responsive and flexible and attune to current quality and regulatory matters. Working with Laura and the team has been a rewarding journey for us.

Barnaby Donion

Here at ILS Group have utilised the services of LFH Regulatory to supplement our Quality & Regulatory offering in times of a heavy workload. Laura and her team have worked and delivered to an extremely high standard on every project they been involved in so far. The team are extremely knowledgeable and great to work with. I look forward to many more collaborations in the future!

Ben

LFH Regulatory has been incredibly helpful in guiding us through complex compliance issues. Their expertise, clarity, and hands-on support made a real difference.

Sam Gifford

We have been partnered with LFH Regulatory since March 2024 with them aiding us in reaching certification to EU MDR, through each challenge we have faced since we first onboarded they have been on hand to aid, finding robust but manageable solutions, dissecting the complex world of modern medical device regulations into clear and concise actions, they really do make regulation simple. They have a diverse team of consultants to provide specific regulatory aid where required covering the full scope of QA/RA queries/ hurdles. As an SME, meeting the ever evolving regulatory frameworks is a real challenge and we couldn't fault their support and knowledge in this space. We would recommend LFH to any company that needs a dynamic, available and trustworthy regulatory consultant by their side.

Meet our
Regulatory Experts

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.

Together, we work closely with our clients to make the process of regulation and compliance as stress-free as possible.