Medical device consultancy
Regulatory, quality, auditing & training for the medical device industry
Led by Alberto Paduanelli, with nearly three decades in medical devices and a background as a senior lead auditor for European Notified Bodies.
What we do
Areas of service
End-to-end support across the lifecycle of a medical device, from a first question to a certified quality system and a product on the market.
Regulatory
Place your device on the market worldwide: CE Marking, UKCA, FDA, Health Canada, ANVISA, TGA, MHLW and MDSAP.
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Quality
Set up, write, review and audit a QMS to ISO 13485, ISO 9001 or 21 CFR Part 820.
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Consulting
Pragmatic help from the awkward first question through to full certification.
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Audit
Internal, supplier and mock certification audits, planned and closed out from start to finish.
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Training
Eighteen courses across QMS, regulations, auditing, risk management, usability and software.
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EU & UK Representation
EU Authorised Representative and UK Responsible Person services for manufacturers outside the EU and UK.
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Nearly three decades of experience
The person you’ll actually work with
Alberto Paduanelli’s experience spans nearly three decades in the medical industry, from R&D to production, quality, regulatory and auditing, including years as a Senior Lead Auditor, Evaluator, Trainer and Certification Manager for European Notified Bodies, among them TÜV SÜD and SGS.
He still provides surveillance, certification and evaluation audits under several Notified Bodies, and continues to help manufacturers build effective quality systems and place their products worldwide.
More about Alberto →Superb reputation
What clients say
I've worked with many consultant QMS auditors. Alberto stands out by a good margin for a multitude of reasons. He knows his topic thoroughly and widely and is wise in its application. I recommend him highly.
Thank you Alpa Medical for the ISO 13485:2016 training. We have learnt a lot about ISO 13485:2016 history and changes this standard ever went through. The training courses are very well-structured and easy to understand even by those who have little experience in this area
I give 'Very Satisfied' marks for everything concerning Alberto Paduanelli, the lead auditor from Futrex's most recent audit. He was exceptional, the best auditor I have ever had the opportunity to work with (and I have worked with at least a dozen auditors over the past 11 years).
Trusted by
Some of the companies we’ve worked with
Get in touch
Tell us what you need
Call, email or use the form. Whatever the market, standard or deadline, you’ll deal directly with a senior lead auditor.
- Email alberto@alpamedical.com
- Phone +44 (0) 7488 713586
- United Kingdom office 29 Rowner Crescent, Hook RG27 0SW, United Kingdom
- Italy office Via Chimienti 8, 72100 Brindisi, Italy