Navigating the Medical Device Approval Process

Welcome to our July newsletter,

As the medical technology landscape continues to evolve rapidly, staying ahead of the curve is crucial for professionals in this dynamic field. At LFH Regulatory, our experts are here to make that journey seamless for you.

We also give you our usual industry insights to keep you up to date on the regulatory landscape.

Read on to find out more...

The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and effectiveness of medical devices before they reach the market. Two primary pathways for regulatory approval are 510(k) premarket notification and the Premarket Approval (PMA) processes. Each pathway has its own requirements, benefits, and challenges. Understanding these can help you choose the appropriate route for your products...

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Welcome to the team Zara

We are thrilled to announce the latest addition to our team, Zara Malik, who joins us as a Senior Regulatory Affairs Consultant. Zara brings a wealth of knowledge and experience in the regulatory affairs domain, particularly within the medical technology sector.

Zara earned her BSc (Hons) in Biological Sciences from the University of Leicester and began her career in 2015 working in R&D for IVDs. Her journey soon led her to focus on Quality and Regulatory roles, specialising in Class I Sterilisation products, Class IIa SaMD, and AIaMDs.

Dr. Yupei Xiao celebrates two Years at LFH Regulatory

This month we had the pleasure of sitting down with Dr. Yupei Xiao, our Clinical and Regulatory Consultant, who is celebrating her second year at LFH. Join us as Dr. Xiao shares her experiences and insights.?

We are incredibly proud to have Dr. Yupei Xiao as part of our LFH Regulatory family. Her dedication, expertise, and positive attitude have significantly contributed to our success. Here's to many more years of innovation, excellence, and growth together.

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Industry Insights

Below are some regulatory intel to keep you up to date with what’s happening across our industry.

Dekra is now designated as a UK Approved Body and scope has been released... MORE

TEAM-NB set up a new date for the MDR technical documentation training for manufacturers... MORE

UK - How to notify the MHRA of your intention to carry out a clinical investigation for medical devices... MORE

UK - Guidance on standardisation for medical devices... MORE

Australia - Regulatory changes for software based medical devices... MORE

Australia - Excluded software Interpretation of software exclusion criteria... MORE

Australia -?Medical device regulation changes... MORE

Last?month, LFH Regulatory proudly celebrated our fifth birthday, marking half a decade of success and growth in the health tech sector. We are thrilled to see our milestone featured across various media outlets, both locally and in the health tech press.

We extend our heartfelt thanks to all the publications for their support and for highlighting our journey.

Here are just a few of the articles covering our celebration:

• Med Tech Innovation
• Medical Plastics News
• Grow Yorkshire
• Hospital Hub
• UK Healthcare Pavilion
• Business Up North
• Health Tech World

We are incredibly grateful for the continuous support from our partners, clients, and the media. Here’s to many more years of innovation, excellence, and growth.