ISO 62304 - Software Lifecycle Processes
Online and In Person
2 days
Date: 13 - 14 February 2023
ISO 13485 - Clause by Clause
Online and In Person
2 days
Date: 14-15 March 2023
Process Validation - What, Why and When?
Online and In Person
2 days
Date: 4 - 5 April 2023
ISO 14971 - Risk Management for Medical Devices
Online and In Person
2 days
Date: 16 - 17 May 2023
How to audit against ISO 13485:2016
In Person only
3 days
Date: 29 - 31 May 2023
How to prepare an MDR or TGA compliant technical file
Online and In Person
1 day
Date: 26 June 2023
INTRODUCTION :
ISO 13485:2016 Is the basis for a Quality Management System (QMS) implemented by medical device manufacturers. This course explores the requirements of the ISO 13485:2016 Quality Management System standard clause by clause.
DURATION: 2 Day training course
FORMAT: On site, at CMS SCIDOC and Online via zoom
WHO SHOULD ATTEND?
LEARNING OBECTIVES:
On completion, you should gain the knowledge and skills to:
COURSE BENEFITS:
This course will help you:
INTRODUCTION :
To help medical device manufacturers understand the Technical File requirements for submitting a compliant technical file for conformity assessment against the MDR 2017/745 and TGA Medical Device Regulations 2022.
DURATION: 1 Day training course
FORMAT: On site, at CMS SCIDOC or Remote
WHO SHOULD ATTEND?
LEARNING OBECTIVES:
This course will help you to understand:
COURSE BENEFITS:
This course will help you:
INTRODUCTION :
The Medical Device Single Audit Program (MDSAP) is developed to allow for a single regulatory audit of a Medical Device manufacturer by a MDSAP recognized auditing organization, to satisfy the needs of multiple regulatory jurisdictions.
DURATION: 3 Day training course
FORMAT: On site, at CMS SCIDOC or Remote
WHO SHOULD ATTEND?
LEARNING OBECTIVES:
This course will help you to understand:
COURSE BENEFITS:
This course will help you:
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