ISO 13485:2016 Medical Devices Quality Management System
Details
Introduction
Global medical device regulatory requirements are continually reviewed and revised to ensure the safety & performance of medical devices place in the markets. The latest version of ISO 13485 standard up to date with the evolving regulatory changes that have occurred since the previous revision in 2003, further aligns with USA 21CFR Part 820 QSR, providing clarifications and new requirements to improve medical device safety and performance.
Course Objectives
Participants will understand how to interpret the regulatory requirements of ISO 13485 and comply with the requirements from the product life cycle perspective.
Who Should Attend?
Key persons of medical devices manufacturer or contract manufacturer.
Course Content
- Introduction
- General
- Scope & Application
- Normative References
- Terms & Definitions
- ISO 13485 QMS Overview
- QMS Documentation
- QMS Cycle
- Application of ISO 13485 throughout the Product Life Cycle
- Conception & Development, Technical File, Customer-related processes
- Risk Management
- Manufacturing
- Work Environment & Contamination Contro
- Human Resource
- Infrastructure & Equipments
- Materials Contro
- Production, Process Control and Process Validation
- Product Monitoring & Measurement
- Packaging, Label & Labeling
- Place on Market
- Use, Maintenance & DisPost Market
Methodology
Lecture and discussions
Schedules
| No. of Days: | 1 |
| Total Hours: | 8 |
ABOUT US
We are an established advisory firm in Systems Assurance and Regulatory Compliance. Specialize in helping our clients to institutionalize simple, effective and integrated system which TRANSCEND the conventional functional boundaries, by bringing peoples and processes together.
System Assurance
A good system assures the consistency of the resulting products and services. We customize, adopt and integrate international recognized standards based Management Systems into the existing operating model and organizational context of our clients.
Regulatory Compliance
Products related regulatory has becoming the new challenge for placing a product in the global market. We provide valuable supports for organizations to compliance with the essential safety and performance requirements for the intended uses of their products.
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