Defining the intended purpose of your medical device early in the design process is essential. This step not only facilitates market access but also influences the development pathway and timelines for your product.
Key Points:
Precision is Essential: Clearly defining the intended purpose helps avoid ambiguities that could lead to differing interpretations of classification rules, potentially resulting in an incorrect risk class.
Impact on Market Access: A well-defined intended purpose is critical for meeting regulatory requirements and ensuring a successful market entry.
This presentation will explore how a precise and well-defined intended purpose can significantly enhance your chances of successfully accessing the market.
Speaker: Laura Friedl-Hirst, Managing Director, LFH Regulatory Limited
LFH Regulatory, a leading regulatory, quality, and clinical consultancy, was founded in 2019 by Laura Friedl-Hirst. The company also provides EU Authorised Representative and UK Responsible Person (UKRP) services. Laura established LFH Regulatory with a clear vision: to create a consultancy and team of experts that adopt a pragmatic approach to guide companies towards their goals, ensuring the regulation and compliance process is as seamless and stress-free as possible.
Laura holds a Bachelor of Science (Hons) in Medical Biology from the University of Huddersfield. With over 12 years of extensive industry experience, she has worked with organisations of various sizes and a diverse range of medical and in vitro diagnostic devices. Her expertise spans regulatory, quality, clinical, and design and development processes, providing LFH Regulatory with a solid foundation of knowledge and leadership.
LFH Regulatory has quickly earned a reputation as a trusted partner in navigating the complexities of Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The company’s dynamic team of professionals is dedicated to building strong, long-term client relationships.
What sets LFH Regulatory apart is its commitment to collaboration and open communication. By understanding each client’s unique challenges and objectives, the team provides bespoke solutions designed to simplify compliance and streamline regulatory pathways. LFH Regulatory works closely with businesses and their products, removing the stress associated with regulatory processes and ensuring clients achieve their goals efficiently and effectively.
Regulation Made Simple
Location: ABHI Stand, Hall 2 (H2.E30)