The founder
Alberto Paduanelli
Alberto Paduanelli’s experience spans nearly three decades working within the medical industry, from R&D to production, quality, regulatory and auditing. This includes working for various European Notified Bodies as Senior Lead Auditor, Evaluator, Trainer, and Certification and Technical Manager.
After obtaining a Bachelor of Science in Electronic Engineering at Northern Illinois University in DeKalb, Alberto moved to England in 2006, where he joined one of the largest manufacturers of infusion pumps and disposables in the world.
It was during his first supplier audit that he knew auditing would be his future career.
That realisation led him to leave the company and join the TÜV SÜD Notified Body, the world’s largest Notified Body for medical devices.
His experience and knowledge of quality standards such as ISO 9001 and ISO 13485, and of regulatory approval requirements such as MDD, MDR and MDSAP, grew exponentially, culminating in the position of Certification Manager at the SGS Notified Body headquarters in the UK.
After hundreds of audits and training sessions delivered worldwide, and the management experience that came with them, a big part of Alberto’s ethos was to help manufacturers succeed in establishing an effective Quality Management System and in placing their products in various countries under the various legislations.
This was the main reason that, back in 2016, Alberto decided to open ALPA Medical, giving him the opportunity to work with the best of both worlds: auditing and consulting.
Alberto still provides surveillance, certification and evaluation audits under several Notified Bodies, and continues to help companies strive for excellence in the healthcare industry, travelling extensively when required, providing public and private training courses, and enjoying what he loves to do most.