How to perform a good Clinical Investigation with Helene Quie

Medical Device made Easy Podcast

Clinical Investigation is one of the toughest process within the EU MDR 2017/745. If you have to perform one for your Medical Devices then it can be a long and expensive process.

In this episode, Helene Quie from Qmed Consulting, will help us understand how to perform it in a good way. This episode will answer some of the questions you have about Clinical Investigation and we hope this will make more clarity for you.

Some of the questions answered are:

• Which products do need a clinical investigation?
• Can we test our products on our employees without a clinical investigation?
• How long does it take and how much does it cost?

Don’t hesitate to go below check the links on the different guidance.

Who is Helene Quie?

CEO at Qmed-consulting – experts in creating value-based documentation for innovative medical devices getting access to the markets through strong and honest partnerships with our clients.

It is my vision to enable better health through close collaborations with large established or newly started medical device manufacturers, small venture based innovative companies, venture funds, notified bodies, hospital, doctors and nurses within a wide range of medical device products and concepts from high-risk complex products such as heart valves with biological tissue to lower risk class products such as dental care products.

I believe that we through our trusted partners and colleagues can change the treatment of sick patients – making sure frontier products reach the patients and end-users, saving patient’s lives.

Together with the Qmed team, I have provided advice and/or operational services for several clients since 2006 within clinical and regulatory affairs, quality management, reimbursement, and health economics and market access with presence through our Qmed team and trusted partners in Europe, US, Canada, India, and Australia.

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 a 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 has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

Link

• Helene Quie Linkedin Profile: https://www.linkedin.com/in/helene-quie-863a323/
• Qmed Consulting: https://www.qmed-consulting.com/
• MDCG 2021-8. https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-8_en.pdf
• MDCG 2021-6: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-6_en.pdf
• MDCG 2020-10: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2020-10-1_guidance_safety_reporting_en.pdf

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