LFH Regulatory Services

Medical Devices

With the ever-changing regulatory landscape and the introduction of the Medical Device Regulation 2017/745, the requirements to bring medical devices to market are challenging.

We provide expert guidance and support to navigate you through the process. Together, we bring your device to market and keep it there.

In Vitro Diagnostics

With the ever-changing regulatory landscape and the introduction of the In Vitro Diagnostic Regulation 2017/746, the requirements to bring In Vitro diagnostics to market are challenging.

Our expertise will navigate you through this process so you can bring your IVD to market and keep it there.

Quality Management

The Medical Device and IVD Regulations have introduced new and more complex regulatory requirements which can impact your Quality Management System.

We implement and maintain Quality Management Systems to ISO 13485, 21 CFR part 820 & MDSAP.

Software As A Medical Device


LFH Regulatory is here to provide you with comprehensive consultancy and support to take your Medical Device Software and Software as a Medical Device (SaMD) innovations to market in a compliant and efficient manner.

We have developed a specialised service that focuses on helping companies successfully navigate the requirements outlined in IEC 62304. This ensures your products can enter the market, fully compliant, faster.

Medical Writing

Proficient and professional medical writing is one of the most important assignments when preparing to bring medical devices to the market. The preparation of clinical or performance evaluation reports and regular updates will be required throughout the life cycle of your device.

We make sure you stay compliant by creating and updating your current evaluation documentation.

UK Responsible Person

Following the exit from the European Union, there have been several changes on how medical devices are placed on the Great Britain market. Non-UK manufacturers are now required to appoint a UK Responsible Person (UKRP) to act on their behalf with the Medicines & Healthcare Regulatory Agency (MHRA).

We can act as your UK Responsible Person (UKRP) and take care of all requirements. This will ensure that your medical devices can be brought to the UK market and you can continue selling them.

Training

We offer bespoke and customised training courses to meet your company and team requirements.

We offer courses such as risk management, ISO13485, Medical Device Regulation/In Vitro Diagnostics Regulation and technical documentation compilation.

Global Registrations

When you are considering global markets, identification of worldwide regulatory requirements is critical.

We help you by providing expertise for these markets for countries - such as the US, Canada, Japan, China and the Middle East.

Regulatory Intelligence Pages (RI)

Regulatory requirements are always evolving. That means maintaining compliance and staying informed of changes is paramount for companies in the medical device industry.

At LFH Regulatory, we offer comprehensive regulatory intelligence (RI) services. Our services are designed to help manufacturers navigate the complexities of medical device regulation with confidence and efficiency.

Creating regulatory framework for IVD 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 have 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 creation, remediation and updating clinical/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 IVD’s and Medical Devices.

Medical team workers examining a medical report
A group of filled laboratory test tubes

Clients Testimonials

  • 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... Read More

    Fionnuala Patterson Avatar Fionnuala Patterson

    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,... Read More

    phil hughes Avatar phil hughes

    During the past few months there has been significant and highly impactful changes to the IVD regulatory pathway that required expert advice to help APIS navigate through, which Laura and... Read More

    Colette Walker Avatar Colette Walker

    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... Read More

    Barnaby Donlon Avatar Barnaby Donlon