FDA Law Blog

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. Prior to joining HP&M, Adrienne worked as an independent regulatory consultant and consultant with Emergo. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical.

Medical 40

Medical Consulting Engineering Manufacturing 40

FDA Law Blog

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. Prior to joining HP&M, Adrienne worked as an independent regulatory consultant and consultant with Emergo. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical.

Medical 40

Medical Consulting Engineering Manufacturing 40

FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. We find that this information is noteworthy for manufacturers to consider.

Manufacturing 45

Manufacturing Engineering Clinic Patients 45

GeriPal

MAY 5, 2022

My great-grandmother in particular had a very profound hearing loss and I don’t know, as a kid, I was obsessed with taking them apart and wanted to do more of the engineering side. And honestly in undergrad I was like, “Engineering is really hard. Hearing aids, you had six big manufacturers of hearing aids.

IT 102

IT Screening Hospital Clinic 102