Medical imaging scanner in a hospital

About

A single expert, with lead-auditor authority

Portrait of Alberto Paduanelli, Founder and CEO of ALPA Medical

Founder / CEO, ALPA Medical Ltd

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.

Career milestones

  1. 2006 Moved to England and joined one of the world’s largest infusion-pump manufacturers.
  2. TÜV SÜD Senior Lead Auditor at the world’s largest medical-device Notified Body.
  3. SGS Certification Manager at the SGS Notified Body headquarters in the UK.
  4. 2016 Founded ALPA Medical, combining auditing and consulting.
  5. 2020 Opened the Italy office and began EU Authorised Representative services.
  6. 2021 Added UK Responsible Person services, a one-stop shop worldwide.

The team

Behind the UK and Italy offices


Portrait of Lalaine Diputado

Lalaine Diputado

Chief Financial Officer

With her experience in finance, a background in management and accounting, and more than 17 years running her own business, Lalaine Diputado supports ALPA Medical with the company accounts and client queries: overseeing client accounts; creating, sending and following up on invoices; quotation proposals; reviewing and performing audits on financial statements and reports; and day-to-day office management.

Portrait of Maurizio Paduanelli

Maurizio Paduanelli

Administrator, ALPA Medical Italia

After specialising in chemistry as a “chemical expert chief industrial technician”, Maurizio Paduanelli continued his university studies in physics.

He worked as a technician and in quality control at Cardinal Health (now CareFusion) in the Basingstoke office (UK), in the field of biomedical equipment, and more specifically on the assembly and testing lines of infusion pumps.

Since 2019 he has collaborated with his brother Alberto, founder of ALPA Medical Ltd, in the field of certifications and consultancy for medical devices, in turn taking on the role of administrator for ALPA Medical Italia, running its day-to-day operations.

Get in touch

Work directly with a senior lead auditor

No account managers, no hand-offs. Tell us what you need and Alberto will reply personally.