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Classroom and Homework Exercises to Make the Regulatory Process Real and Interesting

Biomedical Engineering-Innovation, Design, and Entrepreneurship Alliance 2007 Workshop September 26, 2007 Los Angeles, CA Terry N. Layton, Ph.D. Classroom and Homework Exercises to Make the Regulatory Process Real and Interesting. Department of Bioengineering, University of Illinois, Chicago

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Classroom and Homework Exercises to Make the Regulatory Process Real and Interesting

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  1. Biomedical Engineering-Innovation, Design, and Entrepreneurship Alliance 2007 Workshop September 26, 2007 Los Angeles, CA Terry N. Layton, Ph.D. Classroom and Homework Exercises to Make the Regulatory Process Real and Interesting BME-IDEA 2007 TNL

  2. Department of Bioengineering, University of Illinois, Chicago 1) GMP and Regulatory Requirements for Medical Devices 2) Product Development 3) Technology Assessment & the Start-Up of A Medical Device Company 4) Emerging Medical Technologies 5) Senior Design I & II Make the Regulatory Process Real and Interesting BME-IDEA 2007 TNL

  3. Medical Catheter Selection Product Requirement Definition (PRD) Catheter Complaint Hazard Analysis (HA) Defect/Complaint & Hazard/Harm Catheter Modification 510(k) or Letter to File (LTF) Semester Assignments, Exercises & Oral Presentations BME-IDEA 2007 TNL

  4. Who is using the catheter? Who is it being used on? What procedures? What are the indications? contraindications? What are the sizes or dimensions? When is it used? How is it sold?sterile, non sterile, 6’s, 10’s What other devices is it used with or compatible with? What does it do? What quality or manufacturing tests may be important? Try to list 3 What standards exist? ASTM, ISO, ANSI Catheter PRDWho What Where When Why & How

  5. Define & Provide Example(s), if possible, with your catheter and consider for PRD Accuracy Actual Value Deviation Nominal Range Resolution Homework Assignment BME-IDEA 2007 TNL

  6. Catheter ComplaintHazard/Risk/Solution • Risk Analysis • Identify the hazard • What is the risk? Estimate risks • Where or when did it happen? Company, Hospital, Doctor, Surgery • Risk Evaluation—determine/decide risk acceptability • What do I do about it? CAPA (Corrective Action & Preventative Action) • Recall • Do more tests • Change specifications or label/instructions • Nothing but Monitor • Nothing

  7. BME-IDEA 2007 TNL

  8. Submission 510(k) Decision Tree Design Labeling Manufacturing Process Testing Letter to File(LTF) Documentation Safety & Efficacy Tests & Measurements Catheter Modification 1-5 cm markings 14 Fr Suction Catheter Color- size id Single loop Clear color DeLee tip

  9. BME-IDEA 2007 TNL

  10. BME-IDEA 2007 TNL

  11. Medical Catheter Selection (PRD) Catheter Complaint (HA) Catheter Modification 510(k) or Letter to File (LTF) THANK YOU Terry N. Layton, Ph.D. Visiting Professor,Department of Bioengineering University of Illinois, Chicago tnl@uic.edu Laytech, Inc www.laytechinc.com Tlayton71@aol.com Classroom and Homework Exercises to Make the Regulatory Process Real and Interesting

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