LFH Regulatory is a Medical Device consultancy based in West Yorkshire, United Kingdom. We specialise in delivering compliance solutions in regulatory, quality and clinical for businesses in the IVD, software and general medical device sectors. We have expertise in class I through to class III medical devices including active, implantables and Software as a Medical Device (SaMD), as well as IVD’s.

We work with start-up businesses through to SME’s and global organisations throughout the feasibility, design & development and post launch phases. We understand the difficulties and complexities that marketing devices can bring and work with companies to navigate these.

Our expertise include:

• Quality management system implementation and maintenance
  
• Technical file creation and maintenance
  
• UKRP services
  
• Regulatory strategy
  
• Risk management
  
• Person responsible for regulatory compliance (PRRC)
  
• Clinical and performance evaluation writing
  
• Biocompatibility report writing
  
• Gap analysis
  
• Global registrations
  
• Medical device software
  
• Medical devices and in vitro diagnostic

Our team of consultants have many years’ experience within these fields and can offer you expert advice to make sure you get your device to market and keep it there.

We have established long-term relationships with our clients through understanding their needs, delivery of results, creative thinking and building trust. We understand that running a business, whilst navigating the regulatory landscape, can be difficult at times. We are here to help simplify the process and steer you in the right direction.