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MEDICAL DEVICE TRAINING COURSES OFFERED Q1 and Q2 2023

Medical Device Software

PROCESS VALIDATION FOR MEDICAL DEVICES AND IVDS

Quality Management Systems for Medical Devices

 ISO 62304 - Software Lifecycle Processes

Online and In Person

2 days

Date: 13 - 14 February 2023


Quality Management Systems for Medical Devices

PROCESS VALIDATION FOR MEDICAL DEVICES AND IVDS

Quality Management Systems for Medical Devices

ISO 13485 - Clause by Clause

Online and In Person

2 days

Date: 14-15 March 2023


PROCESS VALIDATION FOR MEDICAL DEVICES AND IVDS

PROCESS VALIDATION FOR MEDICAL DEVICES AND IVDS

PROCESS VALIDATION FOR MEDICAL DEVICES AND IVDS

Process Validation - What, Why and When?

Online and In Person

2 days

Date: 4 - 5 April 2023

Risk Management for Medical Devices

Designing a Regulatory Compliant Technical File

PROCESS VALIDATION FOR MEDICAL DEVICES AND IVDS

 ISO 14971 -  Risk Management for Medical Devices

Online and In Person 

2 days

Date: 16 - 17 May 2023

Auditor Training

Designing a Regulatory Compliant Technical File

Designing a Regulatory Compliant Technical File

How to audit against ISO 13485:2016 

In Person only

3 days

Date: 29 - 31 May 2023

Designing a Regulatory Compliant Technical File

Designing a Regulatory Compliant Technical File

Designing a Regulatory Compliant Technical File

How to prepare an MDR or TGA compliant technical file

Online and In Person

1 day

Date: 26 June 2023


Find out more

ISO 13485 Clause By Clause - 2 Day Training Course

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?  

  • Senior Management
  • Medical device manufacturers
  • Quality Managers
  • Regulatory Affairs Managers
  • Anyone involved with the implementation of the ISO 13485:2016 standard 


LEARNING OBECTIVES:

 On completion, you should gain the knowledge and skills to:

  • Understand how to use ISO 13485:2016 within your organization.
  • Recognize the use of ISO 13485:2016 as the basis of regulatory requirements worldwide.


COURSE BENEFITS: 

  This course will help you:

  • Take the first steps towards ISO 13485:2016 certification 
  • Understand how you can better meet regulatory requirements.
  • Find ways to increase efficiency and cost savings through quality management 
  • Monitor supply chains to achieve continuous improvement
  • Develop safe and effective medical devices 
  • Help you fulfil your company's ISO 13485 training requirements.

DESIGNING A REGULATORY COMPLIANT TECHNICAL FILE

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?  

  • Medical device manufacturers
  • Quality and Regulatory Affairs professionals
  • R&D and Clinical affairs professionals
  • Authorized Representatives
  • Economic Operators, including importers and distributors


LEARNING OBECTIVES:

 This course will help you to understand:

  • What documentation you need for your medical devices
  • Understanding the different technical file requirements for each class of device
  • Understanding the document requirements for each type of device - non-active, active, implantable, drug-device combinations etc


COURSE BENEFITS: 

  This course will help you:

  • Understand what needs to go into a technical file
  • Organisation of your technical file so that the TGA/MDR reviewers can navigate your documents easily

Coming in Q3 2023 - MDSAP TRAINING MODULE

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?  

  • Medical device manufacturers
  • Management
  • Quality and Regulatory Affairs professionals
  • R&D and Engineers


LEARNING OBECTIVES:

 This course will help you to understand:

  • The fundamentals of MDSAP
  • MDSAP audit structure and difference between MDSAP and other QMS audits
  • MDSAP internal audit program
  • The relationships between ISO 13485 and participating regulatory authority compliance requirements


COURSE BENEFITS: 

  This course will help you:

  • To plan and prepare for an MDSAP audit
  • Identify the requirements for your organization for compliance

Express your interest

 CMS SciDoc Pty Ltd 

 Suite 3, 85 Curzon St, North Melbourne, VIC 3051 Australia 

 M: +61 417 534 122