"It was an extremely positive experience working with ALPA Medical. With their professional, focussed and direct working method they could bring us within a short period of time into the position to solve and structure our issues / action plans accordingly. We can 100% recommend ALPA Medical"
Christopher Nabert
International Sales Manager / Venner Medical (Germany)
“Thank you for your time and effort which we believe, thanks to your significant knowledge of the processes involved, we are now much nearer to the closing phase of this important medical device projectfrom the regulatory perspective. We will for sure utilise your company again either within our group of companies and / or future device projects where you can add value.”
Adrian Waterton
Managing Director / Venner Medical (Singapore)
“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.”
Chris Hannan
VP of Quality and Regulatory Affairs / Vision RT Ltd
"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"
Sofia Lysenko
Project Manager / PharmLine Group
“We have had training on two occasions, the ISO 13485:2016 key changes and ISO 19011/13485 Internal Auditor courses, which were both in-house, single day training sessions. The courses are well-structured and include presentations and workshops, dotted with healthy discussions on particular regulatory requirements. The workshops help in grasping concepts more easily and Alberto shares his vast experience during his training programs, providing the much needed perspective of a veteran auditor”
Kenneth Shaw
Regulatory Associate / Advena Medical
“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).“