Is it Easy for a Notified Body to get EU MDR accredited?
We talk a lot about Manufacturers that are under pressure because they cannot find a Notified Body, but today we will also talk about the pressure on Notified Bodies.
Caroline Dore Geraghty, Director of Medical Devices at NSAI is my guest and she will tell us more about the process for Notified Bodies to get accredited. NSAI is an Irish Notified Body and it received its accreditation for EU MDR and can now help its customer.
We will talk about:
The process to get accredited
The possibility to certify the company for EU MDD 93/42/EC
The action of the Notified Bodies during the transition period after the date of application (May 26th, 2021)
The different services that NSAI can offer
NSAI is also looking for auditors so don’t hesitate to contact NSAI if you are interested.
Who is Caroline Dore Geraghty?
Dr. Caroline Dore Geraghty is the Director of medical devices and Head of the notified body. Caroline graduated from the Royal College of Surgeons in Ireland as a medical doctor in 2002 and worked clinically for 12 years.
She holds a masters of science degree in allergy and a diploma in dermatology.
Caroline was head of the clinical team in NSAI for 4 years prior to her promotion to director of the medical devices department.
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 now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
Links from the Video
Caroline Dore Geraghty LinkedIn: https://www.linkedin.com/in/caroline-dore-geraghty-33117452/
NSAI website: https://www.nsai.ie/certification/medical-devices/
Join NSAI: https://www.nsai.ie/about/work-with-us/
Episode 92 – Notified Body audit: https://podcast.easymedicaldevice.com/92/