Engineering IT Manufacturing Medical 
The Medical Futurist
JUNE 21, 2025
However, things are moving fast, and success doesn’t come easy for the pioneers of any medical field. Running trials in animals will take additional engineering and safety tests. How far can you see and hear? When it comes to vision, it’s around 50 miles, talking about hearing, it’s only 1-2 miles at best! Globally 1.1
FDA Law Blog
FEBRUARY 7, 2023
Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. Part 830), post-market surveillance studies (Section 522 of the FD&C Act), medical device tracking (21 C.F.R.
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FDA Law Blog
FEBRUARY 9, 2024
Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.
FDA Law Blog
JANUARY 5, 2022
Lenz has become its first Principal Medical Device Regulation Expert. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. Hyman, Phelps & McNamara, P.C. (HP&M) HP&M) is pleased to announce Adrienne R. Adrienne joined HPM in September 2017.
FDA Law Blog
JANUARY 5, 2022
Lenz has become its first Principal Medical Device Regulation Expert. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. Hyman, Phelps & McNamara, P.C. (HP&M) HP&M) is pleased to announce Adrienne R. Adrienne joined HPM in September 2017.
FDA Law Blog
FEBRUARY 19, 2024
Loloei tackled legal matters related to various aspects of the regulation of medical devices, in vitro diagnostics, and combination products including regulatory and compliance issues, dispute resolutions between the FDA and sponsors, and FDA enforcement actions. During her FDA tenure, Ms. Gibbs , HP&M Director.
FDA Law Blog
FEBRUARY 22, 2023
In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Accordingly, only a subset of 510(k) submissions have historically included HF validation data.
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