Introduction to Regulations for Med-Tech Start Up companies

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.

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Online only

£299.00

Live course via Teams

£399.00

  • 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.

  • 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 and 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

The benefit of this course is that you will be more confident about the entire process of CE marking a Medical Device to commercialise your device in the EU market. Having a CE-marked device opens up doors in other territories in addition to EU.

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