ISO 13485:2016 Medical Devices Awareness

Elevate Your Understanding with ISO 13485:2016 Medical Device Awareness Training

Seminar

2 Dates available

Certificate of Attendance

Virtual learning

8 Lessons

Available online

Seminar Number: PH-C05-ISO13485-Aw-VC

ISO 13485:2016 Medical Device Quality Management System Awareness Training provides a foundational introduction to the internationally recognized standards that govern the quality management systems specific to the medical devices industry. This training focuses on the importance of aligning organizational processes with best practices outlined in ISO 13485:2016 to ensure safety, compliance, and efficiency in the medical device sector.

The program is delivered using a combination of instructor-led lectures, case study and exercises on practical implementation of the concepts discussed within the training. The topics presented below define the areas of focus under the program.

Benefits

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At the end of the training, participants should be able to:

Regulatory Insight: Gain a deep understanding of the requirements necessary for compliance with medical device regulations.
Quality Improvement: Learn the best practices for quality management throughout the product lifecycle.
Risk Reduction: Implement robust risk management processes to mitigate potential issues.
Operational Efficiency: Drive efficiency gains and cost savings through improved processes and operations.
Supply Chain Excellence: Enhance supplier monitoring and product consistency for continuous improvement.

Target group

This training is designed for individuals and teams involved in any stage of the medical device lifecycle, including:

New Employees in the Medical Device Industry
Quality Assurance Personnel
Regulatory Affairs Managers
R&D Professionals
Supply Chain Managers

Requirements

To fully benefit from this training, participants should have:

A foundational understanding of ISO 9001:2015 Quality Management Systems.
Some experience auditing practices is recommended but not mandatory.

No advanced technical skills are required, making this training accessible to anyone looking to enhance their auditing capabilities within the ISO 13485:2016 environment.

Training outline

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Introduction to Quality Management Systems
- Global Approach to Quality
- Definition of Quality
- Quality Philosophies

QMS criteria for business practices
- The Structure of Quality
- PDCA / Deming Cycle
- ISO Quality Management Framework
Clause 1: Scope
- Applicability
- Lifecycle of Product
Clause 2: Normative references
- Reference Documents used (ISO standards)
Clause 3: Terms and definitions
- Acronyms & Abbreviations used in the documentation
Clause 4: Quality Management System
- General
- Documentation

Other information

For payment details and inquiries, please contact academy@phl.tuv.com. Our team will guide you through the payment process and answer any questions about schedules, content, or logistics.

ADDITIONAL INFORMATION

Training fees include materials and a certificate.
Unless stated otherwise, fees are subject to 12% VAT.
A 50% down payment is required before the first day of training. The balance is due on or before the last day.
We accept various payment methods; please reach out for instructions.
For Classroom Trainings, there will be an additional ₱ 1,000 for ancillary costs.

CANCELLATION POLICY

TÜV Rheinland Philippines reserves the right to postpone or cancel public courses due to valid reasons.
Unless cancelled by TÜV Rheinland Philippines, all fees are non-refundable once registration is confirmed.
Cancellations made five days or fewer before the training date are non-refundable; full fees will be charged.
You may nominate a substitute delegate at no extra cost. Please provide their details at least three business days beforehand.

Date selection