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As you may know, the new Medical Device Regulation is asking for more Clinical Data to be able to prove that your product is safe. I am sure that you are wondering about the possibilities for you to collect clinical data for your product.

In this episode, David Rutledge from Global Strategic Solution will share with us 6 ways to collect clinical data for your Medical Devices. He will also help you understand which one is more suitable for your situation.

David also shared with us a presentation that you can download from the links listed below. Don't hesitate to reach our to him if you have more questions.

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► Who is David Rutledge

David R Rutledge, Pharm.D., FCCP, FAHA is a results-oriented consultant for clinical evaluation and investigation, clinical risk management, regulatory, and quality. He brings 25 years’ global experience with agencies such as US FDA, Brazil ANVISA, Mexico COFEPRIS, NMPA (China FDA), S Korea Ministry of Food and Drug Safety, Hong Kong, Malaysia, Health Canada, Australia TGA, Thailand FDA, Japan PMDA, EMA, Saudi FDA, CDSCO of India and several Notified Bodies, e.g., BSI, DEKRA, Medcert, and TÜV SÜD.

He previously accepted a 4-year appointment from the United States Department of Health & Human Services to serve as the Industry Representative on the FDA’s General Hospital and Personal Use Devices Advisory Committee in FDA’s Center for Devices and Radiological Health (CDRH).

He is certified as a Lead Auditor for Quality Management Systems ISO13485 and holds certificates for Design Control, Risk Management, Six Sigma, and CAPA. Dr. David R Rutledge was formerly a Director with Abbott Medical Devices in Global Clinical Research and then Global Regulatory Operations. He has managed budgets up to $23.3 million.

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► Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly 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 created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses...

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► Links from the Video

■ David Rutledge Linkedin: [ Ссылка ]
■ Download Presentation: [ Ссылка ]

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► Social Media to follow

■ Monir El Azzouzi Linkedin: [ Ссылка ]
■ Twitter: [ Ссылка ]
■ Pinterest: [ Ссылка ]
■ Instagram: [ Ссылка ]

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#medtech #medicaldevice #compliance

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