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Description
This BSI course, "ISO 13485:2003 Requirements ", is a competency-based 2-day course that teaches a general understanding of the concepts of the ISO 13485:2003 standard and how its requirements impact the day-to-day operations of organizations in the Medical Device industry.
An experienced instructor explains the clauses of ISO 13495:2003 in detail, providing a base for understanding the Medical Device principles and includes auditing the requirements of the standard. Students learn by particpating in group exercises and in-depth discussions.
This course covers the RABQSA TPECS MD (Medical Device Systems) Competency Unit whose outcome is certified by RABQSA. Attendees successfully completing this course receive a Certificate of Attainment for this RABQSA Competency Unit.
Learning Objective
- Understand the requirements of the ISO 13485:2003 standard
- Learn the fundamentals of quality managements systems
- Auditing to requirements
- How to identify nonconformities
- Purpose and content of an audit report
- Understand Medical Device regulatory requirements compliance framework
Course Materials
Students receive comprehensive course manuals with reference materials.
Audience
- Individuals requiring a working knowledge and understanding of the ISO 13485:2003 standard
- Medical professionals and consultants
- Presidents, Vice-Presidents, and CEOs
- ISO Coordinators and Management Representatives
- Engineers
- Supervisors
- Laboratory quality professionals
- Accredited auditors requiring competency to audit Medical Device Systems
Prerequisite
A prior review of the ISO 13485:2003 standard is suggested for this course. Additionally, it is highly recommended that inexperienced students take the BSI e-learning class, "Overview of ISO 13485:2003", prior to attending the classroom training.
Duration
The course is taught as a one day class, from 8:00 AM - 5:30 PM .
Class Logisitics
There is a test at the end of day 2 of this course. Detailed exam instructions are provided. Certificates of Attainment will be provided for students who are deemed "Competent" for the MD competency unit. Certificates of attendance are provided for those who do not pass the competency test, and students will be given an online opportunity to retake the test.
Class Hours
Day 1: 8:00 AM - 5:00 PM
Day 2: 8:00 AM - 4:00 PM
CEUs
The student certificates display 1.6 continuing education units for the class.
Fee
The course fee is $1095 per student. To confirm your enrollment, pre-payment will be required.
Early Bird Discount
If you pay at least 60 days in advance, you will receive a $100 discount, reducing the fee to $995.
Contact
If you have any questions about this course,
please call us at 770-517-7944 or send an e-mail to Larry@WhittingtonAssociates.com. |
