As a manufacturer of medical devices or In Vitro Diagnostics, you need to be aware of the overall regulations within the markets you distribute. If you are looking to sell globally, you need to have consideration of the bigger picture with regards to what it takes to be compliant across the world. Ensuring you have checked your UK/EU compliance is the first step, but what happens when you want to promote your product further afield?
At LFH Regulatory, we advise you on what it will take to gain access to the global markets you require.
Zara Malik
If you are looking to bring your product to the market on a larger scale, it’s vital to ensure you have an understanding of the local regulatory approval processes in those countries.
Our team of experts is your bridge to access those markets.
We offer support based on our global and local regulatory knowledge and cultural understanding of these processes.
If you are looking for a specific market-access strategy based on global registrations, we provide support in a number of ways:
There is a lot to consider on the subject of global registrations and the regulatory process can differ depending on which market you wish to enter.
At LFH Regulatory, we provide a wide variety of support, ensuring you can get your device to your desired market while being compliant every step of the way.
Contact us today to discuss your requirements and learn more about how we can bring your devices to market.
Get in touch today to find out how LFH Regulatory’s team can help you.
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 and performance evaluations are a vital step in validating the safety and efficacy of your medical devices or IVDs.
Understanding Medical Device and In Vitro Diagnostic (IVD) regulations is complex and requires a comprehensive understanding of the entire product lifecycle.
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Simplify your path to compliance, reach out to our experts today!
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