The Medical Device is growing at an alarming rate, much of this will be in the sectors of nanotechnology, AI, ML and Medical Device Software, Combination devices and more in-home medical Devices and point-of-care testing. With the complications of devices and associated potential risks, regulations have been created to ensure patient safety is paramount. This course is designed for those who need to enter this market but have questions, and need answers.
In this course, you will learn:
- QMS Overview and ISO 13485
- Essential Auditing (Internal, Supplier, External)
- Which region – EU CE marking, US FDA Clearance, UKCA Mark
- Risk and Classification of Devices
- Risk Management ISO 14971: 2019
- Design Control: Design and Development
- Design Validation and Verification Testing
- Bench Testing
- Medical Device Software Vs Hardware
- Overview of essential standards, vertical and horizontal– ISO 10993 (Biocompatibility), ISO 15223 (Symbols in Medical Devices), ISO 20417 (Information for Use), Shipping Testing (ASTMD4169, ISTA), IEC 60601 (Electrical Safety Testing), IEC 62366 (Usability Engineering)
- Preparing a Technical Dossier (DHF or Technical File)
- The Audit
- Gaining Clearance
- Next Steps to Market Entry
- Post Market Surveillance and Complaints, Feedback.
Course Duration: 0.5 to 2 days
Module 1: QMS Overview and ISO 13485 & Essential Auditing (Internal, Supplier, External)
Module 2: Which region – EU CE marking, US FDA Clearance, UKCA Mark, Risk and Classification of devices and Risk Management ISO 14971: 2019
Module 3: Design Control: Design and Development, Design Validation and Verification Testing, Bench Testing, Medical Device Software vs. hardware.
Module 4: Overview of essential standards, vertical and horizontal– ISO 10993 (Biocompatibility), ISO 15223 (Symbols in Medical Devices), ISO 20417 (Information for Use), Shipping Testing (ASTMD4169, ISTA), IEC 60601 (Electrical Safety Testing), IEC 62366 (Usability Engineering)
Module 5: Preparing a Technical Dossier (DHF or Technical File)
Module 6: The Audit, Gaining Clearance, Next Steps to market entry
Module 7: Post Market Surveillance and Complaints, Feedback
This course is ideal for Start-Ups who have never entered the Medical Device world and need a rounded understanding for the next steps after conceptualising an idea from paper to prototype.
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