Monir El Azzouzzi is the founder and CEO of Easy medical device, a swiss based regulatory affairs consulting firm. Monir hosts his own podcast – the easy medical device podcast – where I have had the honor of being a guest on material selection. Monir provides all kind of regulatory affairs services including clinical evaluation, the topic of todays podcast. In our discussion we shed light on the clinical evaluation, clinical tests and on how to argue equivalency.

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Julian Lotz is cofounder and CEO of BIOVOX a german start-up focused on making medical grade plastics more sustainable. He is an expert for sustainable medical grades and especially for biobased grades. In our discussion Julian elaborates on enivornmental impacts, the difference between biobased and biodegradable and on how to make the future of healthcare more sustainable.

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This special episode we will have two guests Mihajlo Milenkovic and Giuseppe Fiandaca. Mihajlo is principal at The Strategists network a strategy consulting firm focused on medical technology. Giuseppe Fiandaca is Cofounder and Managing Director at Polyneers a consulting firm for medical grade plastics. Together with Gradical these two companies jointly put together a market report regarding the medical grade plastic market. More info on the market report under www.medicalgradeplastics.de

Still looking for more regarding plastics in medical technology?

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Check out our market report on medical grade plastics.

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Dr. Stefan Rössler is an expert for the massbalance approach and auditor for massbalance certifications at TÜV-SÜD. After his PhD in chemical engineering he worked a couple of years in industry as a business and technical consultant before he joined TÜV SÜD as an auditor and global product manager for ISCC certifications. We talk in detail about different chain of custody options, sustainable feedstocks and the ISCC-PLUS certification process.

Still looking for more regarding plastics in medical technology?

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Check out our market report on medical grade plastics.

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Vinny Sastri is an expert in quality management and medical grade plastics. He holds a PhD in Chemistry from the Rutgers University. After a stellar career at BASF, Honeywell and GE-Plastics he founded his own consultancy where he focuses on quality management. He is a certified Six Sigma black belt and his book plastics in medical device is without peers. He recently started as senior vice president global quality at Avanos medical a company providing solutions for Pain Management and Chronic Care. Lets hear our discussion!

This episode was sponsored by www.avanos.com

Here a link to the book "Plastics in Medical Device": https://amzn.to/4gVldHf

Still looking for more regarding plastics in medical technology?

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Check out our market report on medical grade plastics.

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Kim Laursen is the Managing Director of Melitek A/S a medical compounder based in Denmark. With his nearly 30 year of experience he is a true expert in the field of medical compounding. In our discussion we talk about what advantages a compounder dedicated to medical end market brings, about sustainability and how to attract key talent.

This episode was sponsored by Melitek

Still looking for more regarding plastics in medical technology?

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Check out our market report on medical grade plastics.

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Jonathan Demierre is an expert for eco-design and lead the team Sustainability Engineering at Helbling. He holds a PhD in Energy Systems from the EPFL Lausanne and worked at the Sustainable Engineering Lab of Columbia university in New York before joining Helbling. His whole career is centred around sustainability and eco-design. We talk about the sustainability and how it is embedded in the design process and why you should not put goals on means.

Still looking for more regarding plastics in medical technology?

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Check out our market report on medical grade plastics.

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Steve Maxson is an expert for medical extrusion and currently Innovation and Business Developer at US-Extruders. He has over 20 years of experience in the medical extrusion business and hosts his own podcast Med-Ex The Medical Extrusion Podcast where he covers all things medical extrusion. On the side he also runs his own consulting business maxsoninsightservices.

In our discussion we talk about catheter manufacturing, PFAS, regulatory topics and sustainability.

Still looking for more regarding plastics in medical technology?

Visit our website and inform yourself on the services of Gradical.

Check out our market report on medical grade plastics.

Attend a training regarding material compliance at the KATZ or the SKZ.

Sign up to our news letter and never miss an episode.