Albert "Skip" Farinha
Skip has over twenty-five years of experience in the US and European medical device field with experience in Manufacturing, Operations, Compliance, Quality Engineering, Regulatory and Clinical trials for Class I, II, III devices and Combination Products, with knowledge of OTC consumer products, ultrasonic devices, lasers, imbedded software, orthopedic implants, woven and non-woven textile implants and reusable devices.
He has presided over Pre-IDE meetings at FDA proposing regulatory and clinical strategies for a novel dialysis port system and ultrasonic skin permeation systems for drug delivery and analyte extraction.
He has experience with IDEs, 510Ks, PMAs, DeNovo 510Ks, Combination Device submissions, NDAs and OTC drugs. He has conducted and overseen clinical trials in both the US and EU for minimal risk and implanted devices. He has extensive experience in compliance remediation and 483/Warning Letter responses.
In addition to QA/Regulatory/Clinical experience he has extensive operations experience setting up facilities for engineering, production and wet labs which have included validation activities for machining processes, form fill seal packaging, aseptic fill, sterilization processes, cleaning and reprocessing, design testing and product life validations.
His background is mechanical engineering with a strong manufacturing background.