Leo J. Lagrotte-former Medical Device FDA Investigator Leo served 20+ years experience with the FDA and USDA in a number of capacities as an FDA investigator, Level II Certified Medical Device Investigator (one of forty-four nationally) in 2005, and also served on FDA’s Medical Device Inspection Cadre.
During his time at FDA, he conducted 500+ domestic and foreign inspections of Medical Device, Laser, and X-Ray manufacturers.
FDA Personnel Trainer
With FDA, I served as a trainer or new-hire investigators in the Florida District, in formal training classes as well as field OJT in Medical Device QSIT inspections, Food Safety, GMPs and regulatory photography.
I trained medical device investigators throughout the Southeast Region of FDA in Laser Performance Standards for medical and non-medical laser products, and incorporating the QSR and EPRC regulations in medical laser products.
I have participated in FDA/Industry seminars and have participated as a guest speaker on FDA medical device regulations, FDA careers day for local schools; RAPS meetings; AdviMed training course, University of South Florida Graduate training program in Medical Device Manufacturing.
Presently, Mr. Lagrotte’s focus is to assist the medical device and radiation health manufacturers in meeting or exceeding compliance with all FDA regulations and Notified Body requirements for certifications, completing 510(k) and PMA submissions and responding to regulating officials as necessary on behalf of clients.
My Approach to Quality Systems Inspections…
Is usually based on the “risk approach,” meaning that the intended use of the device to treat, mitigate or diagnose an ailment requires all aspects of control in design, production and distribution to include in-depth evaluation of the human interface with the device to determine the possibilities of malfunctions, which could lead to serious injury or death. The device must be user friendly and IFUs must be incorporated for ease of comprehension. Electronic interfaces with hands on controls require extensive testing to ensure that the intended output is produced by the setting control.