IEC 62304 Update: Powerful Changes You Need To Know And Why They Matter
February 25, 2025
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Read More » You’ve made an innovative and life-changing medical device or IVD that the market needs. The next step, is navigating the ever-changing world of regulation and getting it to market. Our agile team of experts can guide and support you with consultancy, regulatory documentation writing, UKRP, quality management & more.
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No matter what you need support with, our range of services can support you right from product inception through to post-market monitoring, helping you have a cohesive system that gets your product to market and keeps it there. Our services:
Founded in 2019 by Laura Friedl-Hirst, our company has quickly grown into a dynamic team of passionate professionals. Together, we work closely with our clients to make the process of regulation and compliance as stress-free as possible.
What truly sets LFH Regulatory apart is our commitment to building strong, long term relationships with our clients. We believe that collaboration and open communication are vital in understanding your unique challenges and goals. By working closely with your business and product, we can provide tailored solutions that remove the stress from Medical Device Regulation and In Vitro Diagnostic Regulation.
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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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