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 a leading consultancy when it comes to regulatory framework for IVD’s and Medical Devices.
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
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
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
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