Medical Device Design & Development Control. ISO 13485.

📚 Course Overview: Medical Device Design & Development Control. ISO 13485

🚀 Your Pathway to Market Approval Begins Here!

Are you ready to master the intricacies of medical device design control and navigate the complex landscape of global regulatory compliance? Our comprehensive online course, "Medical Device Design & Development Control. ISO 13485," is tailored for professionals seeking to understand and implement the standard requirements for medical device design and development control, paving your way to obtain market approval in the EU, US, and worldwide.

🔍 What You'll Discover:

• The Standard Explained: Gain clarity on what ISO 13485 requires from medical device designers for compliance and market entry.
• Global Compliance: Learn how to comply with MDR 2017/745 in the EU, CFR 820.30 in the US, and global standards.
• Real-World Application: Utilize practical examples, like the design of a stent, to enhance your understanding throughout the course.

🔍 Course Structure & Key Topics:

Section 1: General/Design & Development Planning 📐

• Explore the initial planning stages of design and development as per ISO 13485, section 7.3.1 & 7.3.2.
• Understand the importance of documentation to support your medical device's design and development process.

Section 2: User Needs/Intended Purpose 🤝

• Define the "Intended Purpose" of your medical device and identify user needs from a variety of sources.
• Recognize the significance of stakeholder input and how it can impact your design process.

Section 3: Design & Development Inputs ➡️🔄

• Translate user needs into tangible design solutions.
• Master the IOVV (Input Output Verification Validation) matrix to ensure traceability throughout the design and development phase.

Section 4: Design & Development Review 👀

• Conduct thorough reviews at each stage of the design process, ensuring that all steps are documented and approved by a designated authority within your organization.

Section 5: Design & Development Verification ✅

• Grasp the concepts of verification as defined by ISO 13485 and understand its role in ensuring the specifications of your device are accurate.
• Learn through examples how to conduct verification tests effectively.

Section 6: Design and Development Validation 🔍

• Dive into the validation requirements of ISO 13485 and comprehend it in simple terms.
• Confirm that your medical device performs as intended within real-world conditions.

Section 7: Design and Development Transfer 🚢

• Understand the design transfer process and its critical role in transitioning from development to production.
• Analyze a case study illustrating the importance of design transfer for market success.

Section 8: Design and Development Changes ✏️

• Master the control of design changes and learn how to document these modifications effectively.
• Explore a case study that underscores the importance of managing changes in design control.

Section 9: Design and Development Technical files 📂

• Delve into the documentation required for design control, including the Design History File, Device Master Record, and Device History Record.
• Understand the technical file requirements associated with EU regulations.

Section 10: Bringing It All Together 🎓

• Ensure that your entire design control process is documented, recorded, and stored as required by ISO 13485.
• Gain insights into maintaining a complete Technical Documentation set to satisfy global regulatory expectations.

🎉 Why Choose This Course?

• Expert Guidance: Learn from an instructor with extensive experience in medical device design and development.
• Practical Examples: Apply concepts learned through real-world scenarios and case studies.
• Flexible Learning: Study at your own pace, with lifetime access to course materials.
• Global Standards: Understand the requirements of various regulatory bodies across different regions.
• Certificate of Completion: Earn a certificate to showcase your new expertise in medical device design and development control.

📅 Enroll Now and take the first step towards becoming an expert in medical device design & development control, backed by ISO 13485 standards! 🚀💉

Embark on this journey with us and transform your career in the medical device industry. Sign up today and unlock the door to compliance and success!