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Do you need a Cleanroom for your Medical Devices? [Philippe Bourbon]

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Episode 190
33 min / Published

Cleanroom is an equipement that a lot of Medical Device manufacturer need to have. But do you really need it? How much does it cost? How to qualify it? How to maintain it? Philippe Bourbon from Groupe Icare Laboratory will help us understand all that. Check also the summary provided as a download.

Who is Philippe Bourbon?

Physician, passionate about topics related to particulate, microbiological and chemical contamination on industrial sites and health sectors. 30 years of experience, knowledge in a Cofrac and cGMP / BPF environment, Consulting / Training, Expert in contamination control, and sterilization processes, Sales, Technical Developments, Management of technicians, managers and salespeople , Activity Manager. Expertises: Sterilization by heat, S.I.P., Ethylene oxide, depyrogenation, cleanrooms and controlled environment, microbiological and chemical confinement, climatic and thermostatic chambers, compressed gas Pharmaceutical Regulation (GMP / cGMP), Medical Devices, Standards (ISO14644, ISO17665, FDX15-140, …) Diagnosis / Consulting / Validation strategy / Qualifications / Audits / Trouble shooting

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and notably Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now made the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses…

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Medical Device made Easy Podcast
A podcast by easymedicaldevice
Helping you placing compliant medical device on the market.
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