How to get ISO 13485 certified? (Quality Management System)

Medical Device made Easy Podcast

In this episode of the Medical Device made Easy Podcast, I wanted to answer a recurring question I receive with as much detail as possible. The question is: “How to get ISO 13485 certified?”

As Easy Medical Device is a consulting agency helping Medical Device manufacturers to place compliant medical devices on the market, most of our clients have no experience in the Medical Device Regulations.

So in this video, I will answer this question.

AGENDA

• What is ISO 13485?
• Who can provide this certificate?
• How much does it cost to get ISO 13485 certified?
• Frequency of the audits
• What contains ISO 13485?
• ISO 13485 certified versus US FDA 21 CFR part 820
• ISO 13485 within the MDSAP program
• Easy Medical Device support

Don’t hesitate to reach Easy Medical Device to get some support on your QMS certification process. Or any other Quality and/or Regulatory affairs question.

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, Bausch and Lomb or BBraun Medical, 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…

Links for ISO 13485

• 5 Steps to create a Quality Management System: https://easymedicaldevice.com/5-steps-quality-management-system/
• How to verify a certification body?: https://easymedicaldevice.com/accreditation-certification-body/
• Best Tips: ISO 13485 procedures with our free template: https://easymedicaldevice.com/iso-13485-procedure/
• ISO standard: https://iso.org
• Harmonized Standard MDD 93/42/EC: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
• Harmonized Standard AIMDD 90/385/EEC: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/implantable-medical-devices_en
• Harmonized Standard IVDD 98/79/EC: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_fr
• QMS for economic Operators: https://easymedicaldevice.com/economic-operators/
• How to prepare for an Audit article: https://easymedicaldevice.com/medical-device-audit/
• Episode 10 – What is MDSAP?: https://podcast.easymedicaldevice.com/10/
• MDSAP article: https://easymedicaldevice.com/mdsap/
• FAQ article: https://easymedicaldevice.com/faq-iso-13485/

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