MEDICAL DEVICE TRAINING COURSES OFFERED Q1 2025
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
3 days
Date: 29 April - 1 May 2025
Quality Management Systems for Medical Devices
PROCESS VALIDATION FOR MEDICAL DEVICES AND IVDS
PROCESS VALIDATION FOR MEDICAL DEVICES AND IVDS
ISO 13485 - Clause by Clause
Online and In Person
2 days
Date: 6-7 May 2025
Medical Device Software
PROCESS VALIDATION FOR MEDICAL DEVICES AND IVDS
Risk Management for Medical Devices
ISO 62304 - Software Lifecycle Processes
Online and In Person
2.5 days
Date: 20-22 May 2025
Risk Management for Medical Devices
Designing a Regulatory Compliant Technical File
Risk Management for Medical Devices
ISO 14971 - Risk Management for Medical Devices
Online and In Person
2.5 days
Date: 23-25 June 2025
Auditor Training
Designing a Regulatory Compliant Technical File
Designing a Regulatory Compliant Technical File
How to audit against ISO 13485:2016
In Person only
4 days
Date: Express your Interest
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: Express your Interest
If you are interested in in-house training please feel free to contact us via info@cmsscidoc.com
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 Q1 2025 - 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: 3.5 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
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