MPD Training Course: The Fundamentals of Audits for Medical Devices
9th October 2018 @ 9:00 am - 4:00 pm
MedilinkWM and Medical Device Consultancy Ltd bring to you practical Training Courses designed around the delegate. These intimate sessions are designed to maximise learning outcomes and are created to promote interaction and discussion.
This one-day course is designed for those who need to better understand what medical device audit is, what it is trying to do, how to do it, and when it is required. There is a fee for this course, please see below for more details and your invoice will be forwarded to you on receipt of your registration.
You might be new to medical devices, about to get involved with internal audit, perhaps you are thinking of becoming an auditor? Perhaps you are a senior manager who wants to know the fundamentals to help you manage your team?
In just one day, the course will cover:
Role of the key players in Europe: Competent Authorities and Notified Bodies.
Where to find key guidance so you can answer the exam question!
Standards you can learn from.
What is the ‘Blue Guide’ and why it is so important.
Notified Body Unannounced Audits and the effect on the supply chain.
Differences between Competent Authority and Notified Body Audits.
MDR/IVDR and ISO 13485: 2016 and effect on audits. Insights about United States (US) Food and Drug Administration (FDA) Inspections.
Comments on the Medical Device Single Audit Program (MDSAP) and why this matters so much to those who want to market to Canada!
The Direction of Travel!
What is CE marking and why the ‘Blue Guide’ matters.