MEDICAL DEVICE TRAINING COURSES OFFERED Q1 and Q2 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?  

• 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.

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

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