Instructor :
Charles H. Paul

Webinar ID:
2935

🌟 Unlock the Potential of Quality Management in Your Organization! 🌟

Ever wondered how ISO 13485 can revamp your medical device enterprise? Dive into the heart of international quality management with us.

The ISO 13485: It’s not just any quality standard, it’s THE quality management system standard for medical devices.

What’s its main gig? It’s there to “specify requirements for a quality management system where an organization showcases its prowess in delivering medical devices and services that are up to par with both customer expectations and regulatory requirements.”

Got roots in ISO 9001, did you say? Absolutely! But with time, it’s morphed into its own formidable version.

🚀 Join our dynamic 4-hour webinar, broken down into 6 enlightening sections, each zeroing in on a crucial facet of the standard, right from its core to the coveted certification:

1. The Aha Moment – Introduction
2. The Nitty-Gritty – ISO 13485 Requirements
3. The Showdown – QSR vs. ISO Compliance
4. Level Up! – Training for ISO 13485
5. The Blueprint – ISO 13485 Documentation Requirements
6. The Final Frontier – Getting Certified

🔍 What’s in Store?

• Kick things off with a comprehensive peek into the quality management system concept, touching both the QSR and ISO standard territories.
• Ever pondered the real impact of ISO 13485? We’ll delve deep into its essence, its significance, and its ultimate mission.
• Let’s clear the air on 21 CFR820 vs. ISO Standard. It’s all about grasping the thin line between conformance and compliance.
• At the seminar’s core? A thorough analysis of the essential training, the documentation dynamics, and the path to certification.
• Cap it off with a strategic discussion on implementing your quality system in line with the standard.

Ready to be in-the-know? Join the conversation and elevate your organization’s quality game.

Hop on board! 🚀🌟

🌟 Unlock the Potential of Quality Management in Your Organization! 🌟

Ever wondered how ISO 13485 can revamp your medical device enterprise? Dive into the heart of international quality management with us.

The ISO 13485: It’s not just any quality standard, it’s THE quality management system standard for medical devices.

What’s its main gig? It’s there to “specify requirements for a quality management system where an organization showcases its prowess in delivering medical devices and services that are up to par with both customer expectations and regulatory requirements.”

Got roots in ISO 9001, did you say? Absolutely! But with time, it’s morphed into its own formidable version.

🚀 Join our dynamic 4-hour webinar, broken down into 6 enlightening sections, each zeroing in on a crucial facet of the standard, right from its core to the coveted certification:

1. The Aha Moment – Introduction
2. The Nitty-Gritty – ISO 13485 Requirements
3. The Showdown – QSR vs. ISO Compliance
4. Level Up! – Training for ISO 13485
5. The Blueprint – ISO 13485 Documentation Requirements
6. The Final Frontier – Getting Certified

🔍 What’s in Store?

• Kick things off with a comprehensive peek into the quality management system concept, touching both the QSR and ISO standard territories.
• Ever pondered the real impact of ISO 13485? We’ll delve deep into its essence, its significance, and its ultimate mission.
• Let’s clear the air on 21 CFR820 vs. ISO Standard. It’s all about grasping the thin line between conformance and compliance.
• At the seminar’s core? A thorough analysis of the essential training, the documentation dynamics, and the path to certification.
• Cap it off with a strategic discussion on implementing your quality system in line with the standard.

Ready to be in-the-know? Join the conversation and elevate your organization’s quality game.

Hop on board! 🚀🌟

🎯 Reap the Rewards of ISO 13485: More Than Just a Standard! 🎯

Let’s get one thing straight: ISO 13485 is a standard, not a regulation. In the US, grasping this difference is more than just a play on words – it’s the key to bypassing serious compliance pitfalls.

So, what’s the big deal about this standard? 🤔

• For medical device manufacturers, it’s not just any standard—it’s THE benchmark for their quality management systems.

Why should this matter to you?

• Boost Market Presence: Certification isn’t just a badge—it unlocks doors to global markets demanding this standard’s adherence.
• Optimize Your QMS: The ISO standard isn’t just about compliance. It’s a golden ticket to enhancing, maintaining, and executing your Quality Management System. Just ensure you’re in the know about the nuances between country regulations and this standard.
• A Streamlined Framework: ISO 13485 offers a clear roadmap for medical device quality, urging a holistic systems approach.

Feeling overwhelmed with the thought of adding another layer to your compliance cake? 🎂
Don’t fret! Our seminar aims to simplify the complex, guiding you towards seamless integration.

🚀 Unlock the potential of ISO 13485! Embrace a smarter, more efficient quality journey.

Sign up now! 🚀

🎯 Reap the Rewards of ISO 13485: More Than Just a Standard! 🎯

Let’s get one thing straight: ISO 13485 is a standard, not a regulation. In the US, grasping this difference is more than just a play on words – it’s the key to bypassing serious compliance pitfalls.

So, what’s the big deal about this standard? 🤔

• For medical device manufacturers, it’s not just any standard—it’s THE benchmark for their quality management systems.

Why should this matter to you?

• Boost Market Presence: Certification isn’t just a badge—it unlocks doors to global markets demanding this standard’s adherence.
• Optimize Your QMS: The ISO standard isn’t just about compliance. It’s a golden ticket to enhancing, maintaining, and executing your Quality Management System. Just ensure you’re in the know about the nuances between country regulations and this standard.
• A Streamlined Framework: ISO 13485 offers a clear roadmap for medical device quality, urging a holistic systems approach.

Feeling overwhelmed with the thought of adding another layer to your compliance cake? 🎂
Don’t fret! Our seminar aims to simplify the complex, guiding you towards seamless integration.

🚀 Unlock the potential of ISO 13485! Embrace a smarter, more efficient quality journey.

Sign up now! 🚀

Part 1 – Introduction

• Overview/basic elements of the quality management system
• Typical quality system elements
• Purpose of ISO 13485
• Key attributes of a functional quality system
• ISO 13485 content overview and evolution of revisions

Part 2 – ISO-13485 Requirements

• Review of the regulation: What the standard is asking you to do

Part 3 – QSR vs ISO Compliance

• What is the QSR
• What is the difference between the QSR, ISO 13485 and other regulatory requirements/standards?
• How do you implement your quality system in conformance with the standard?

Part 4 – Training for ISO 13485

• Regulation training requirements
• Who needs to be trained?
• What is the best means of training?
• How is training conducted and verified?
• Evaluating staff regulation competency

Part 5 – ISO-13485 – Documentation Requirements

• What needs to be documented?
• What are regulatory expectations for that documentation?

Part 6 – Getting Certified

• Is getting certified right for our company?
• The certification process

Part 1 – Introduction

• Overview/basic elements of the quality management system
• Typical quality system elements
• Purpose of ISO 13485
• Key attributes of a functional quality system
• ISO 13485 content overview and evolution of revisions

Part 2 – ISO-13485 Requirements

• Review of the regulation: What the standard is asking you to do

Part 3 – QSR vs ISO Compliance

• What is the QSR
• What is the difference between the QSR, ISO 13485 and other regulatory requirements/standards?
• How do you implement your quality system in conformance with the standard?

Part 4 – Training for ISO 13485

• Regulation training requirements
• Who needs to be trained?
• What is the best means of training?
• How is training conducted and verified?
• Evaluating staff regulation competency

Part 5 – ISO-13485 – Documentation Requirements

• What needs to be documented?
• What are regulatory expectations for that documentation?

Part 6 – Getting Certified

• Is getting certified right for our company?
• The certification process

FUNCTIONS

• Marketing
• Research & Development
• Technical services
• Manufacturing
• Compliance and regulatory
• Logistics/supply chain
• Service and maintenance

POSITIONS

• Associates
• Supervisors
• Managers
• Directors
• Vice Presidents

FUNCTIONS

• Marketing
• Research & Development
• Technical services
• Manufacturing
• Compliance and regulatory
• Logistics/supply chain
• Service and maintenance

POSITIONS

• Associates
• Supervisors
• Managers
• Directors
• Vice Presidents