Laura Friedl-Hirst, the Principal Consultant and Managing Director of LFH Regulatory, a Leeds-based medical device and in vitro diagnostic regulatory consultancy spoke recently at the Med-Tech Innovation Expo about the latest update to UK medical device regulation.
Laura’s panel at Med Tech Expo discussed the latest updates in the MedTech Regulatory landscape. Throughout this panel, one of the main topics discussed was the impact of Brexit on medical device compliance and manufacturers, which is an area that still holds much uncertainty.
Whilst there is excitement around the new UK Medical Devices Regulation and the fact that this will be specific to what the UK market needs, the lack of clarity around what companies need to supply Great Britain is an ongoing issue.
Despite this, Laura and her team have been helping their clients navigate these uncertainties by understanding their market strategy and applying the appropriate regulation to efficiently get their product to market.
Laura states “Our main aim is always to alleviate the stress that can come with medical device regulation, and we never want to delay our clients in going to market. Due to this, we are working with the current requirements until we receive a draft text of the new UK Medical Devices Regulation from the government, which is hopefully very soon.”
Laura, alongside two other panellists also discussed a range of topics during MedTech Expo, these included:
– How recent fast-track approvals from EU, U.S. and Japan may affect the UK. – International regulations: The effect on UK innovators, and the effect on overseas innovators coming to the UK. – The similarities and differences with the medical device and pharmaceutical sectors. – Software as a medical device (SaMD) challenges.
Laura has a unique perspective on medical device regulation, after deciding to set up LFH Regulatory once she noticed a gap in the medical regulation market for consultancies that cover all areas. Many medical device regulatory consultancies don’t offer all their services under one roof unlike LFH Regulatory. This unique offering allows LFH Regulatory to provide tailored solutions to their clients to make the process of regulation and compliance as stress-free as possible.
MedTech Expo came soon after LFH Regulatory celebrated their fourth birthday at the start of June. Since starting out, LFH Regulatory has grown to a team of nine and the business had acquired a multitude of clients. This growth has also allowed each team member to hone their skills and specialise within different areas of the business, in turn creating a team of experts under one roof.
To learn more about LFH Regulatory and their services please visit their website – https://lfhregulatory.co.uk/