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Home » Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements

Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements

Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements Certification Training


Program/Course ID:MDG2
Enrollment Period:12 months.
Average Learning Time:~.
Additional Resources:Supplemental materials/activities.
Credit Hours:3 credits.
Method of Training:
Online, asynchronous, self-paced eLearning.
Accessibility:24/7 access to all program materials.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.

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Outline:


INTRODUCTION
1. Welcome
2. Introduction
3. Assessment

THE STANDARD
4. Why Use ISO13485:2003?
5. Applying ISO13485:2003
6. Defining A QMS
7. Review

THE QMS
8. Introduction
9. Key Areas Of The QMS
10. ISO9000 Vs ISO13485
11. Resource Management
12. Product Realization
13. Planning For Product Realization
14. Customer-Related Processes
15. Design & Development
16. Purchasing & Vendor Assurance
17. Production & Service Provision
18. Control Of Production Processes

ANALYSIS, IMPROVEMENT & DOCUMENTS
19. Measurement & Analysis I
20. Measurement & Analysis II
21. Measurement & Analysis III
22. Improvement
23. QMS Documentation
24. Company Responsibilities
25. Review I
26. Review II

CERTIFYING THE QMS
27. Iso 13485 Certification
28. What To Expect During An Audit
29. Review

CONCLUSION
30. Summary

GLOSSARY/RESOURCES

Objectives:


State how ISO 13485:2003 relates to the medical device industry
Identify the key areas of and resources needed for the Quality Management System (QMS)
Identify some key roles in administration of the QMS
Recognize how the QMS is to be certified by an external auditing authority.

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Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
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Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
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