ISO 13485 Training

Course code: DQMS01

Overview

This introductory course covers the basic requirements of ISO 13485 and its implications within a medical device manufacturing company.

As the ISO Standard 13485-2003 Medical Devices states;

"All requirements of this International Standard are specific to organizations providing medical devices, regardless of the type or size of the organization."

Course Duration & Location

One day, on your site or at an offsite location.

PharmOut's training courses can be delivered anywhere in the world. If your site is not in a city we have an office in then we ask you to cover the travel costs from our nearest office. You'll save the costs associated with your staff travelling to be trained, so it becomes cost effective if you have several people needing training.

Pricing

Indicative pricing is A$500 per person or A$4500 per day, with discounts available when more than 10 people attend the same course.

What you will learn

Upon completion of this course participants will be able to;

• understand the definition of a Medical device and what 'intended use' actually means for 13485 compliance
• understand the intent and scope of the 13485 standard
• have a practical, working knowledge of the 13485 and people's responsibilities in maintaining compliance with this Standard
• know how to practically implement the fundamentals of 13485
• realise the importance of 13485 compliance
• understand the processes that drive the 13485 Standards
• implement documentation regulations for procedures, work instructions and records

Course materials

Participants will receive a copy of the presentation(s), relevant notes and workshop materials.

A certificate of completion will be issued to participants who successfully complete the assessment.

Assessment

A written assessment is conducted at the end of the course.

Course Format

The course is a combination of lecture-style learning and active workshops with participants working in small groups on assigned tasks.

Who should attend?

• Operations / Manufacturing personnel
• Quality Assurance personnel
• Quality Control personnel

More information

If you would like a quote or would need to ask questions, please contact us.