Shyam Srinivasan

Experience

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  Technische Universität München

  Jun 2015 - Jul 2015

  Project Intern

  CNT- based Biosensors for pH detection

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  HelmholtzZentrum München

  Apr 2018 - Jun 2020

  Wissenschaftlicher Mitarbeiter

  Laser diodes and high-frequency drivers. I worked on a novel endoscopic device for oesophageal cancer as part of the ESOTRAC project - an EU-funded research consortium based on a novel imaging platform called Optoacoustics.

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  MedInnovate

  Oct 2018 - Mar 2019

  Fellow
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  OSRAM

  Jun 2020 - Sept 2020

  Trainee
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  Dymium

  Nov 2020 - Aug 2024

  Co-founder & Regulatory Lead

  Dymium developed a novel method for the residue-free removal of kidney stones using magnetic separation technology. 4+ years leading technical development and approx. 3.5 years leading RACA at Dymium GmbH. Dymium GmbH developed a new medical device for the complete removal of kidney stones in ureterorenoscopy (MDR class IIb). After the first year as Head of Technical Development, I enforced the company's risk policy and DIN EN ISO 13485, 21 CFR 820 and MDR compliant quality policy, formulated the regulatory and clinical strategy and led the De Novo classification in the US and the MDR Annex IX certification process in Germany. My team also planned and conducted an in vivo validation of this device in large animals to acquire data on (un)foreseeable risks and held pre-submission meetings with the FDA to obtain feedback. Show less

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  Fresenius Kabi Deutschland

  Aug 2024 - now

  Quality Manager - Compounding Devices