Annual Medical Device Quality Congress Presentations
Click on the presentation title to view the presentation |
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Tuesday, April 23, 2019 — PRE-CONFERENCE WORKSHOP | |
8:30 a.m. – 12:00 p.m. |
Correction and Corrective Action — Dissipate the Fog of Confusion
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Tuesday, April 23, 2019 — DAY 1 | |
1:15 p.m. – 2:00 p.m. |
FDA’s 2019 Medical Device Regulation Agenda: Are you Prepared?
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2:00 p.m. – 2: 45 p.m. |
Medical Device Risk Management: 2019 revision, EU MDR, and Software Risk
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3:15 p.m. – 4:45 p.m. |
Moderator:
Panelists
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Wednesday, April 24, 2019 — DAY 2 | |
9:00 a.m. – 9:45 a.m. |
Enacting the Case for Quality: Defining Metrics
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9:45 a.m. – 10:30 a.m. |
Regulating Software Used by Life Science Manufacturers: Is it a Medical Device or Not?
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11:00 a.m. – 12:00 p.m. |
Sampling Plans for Quality Audits
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1:00 p.m. – 2:00 p.m. |
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2:00 p.m. – 2:45 p.m. |
FDA’s Focus on Risk Management and Cybersecurity for Devices that Contain Software
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3:00 p.m. – 4:30 p.m. |
Moderator:
Panelists:
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Thursday, April 25, 2019 — POST-CONFERENCE TRAINING | |
8:30 a.m. – 5:30 p.m. |
Post-Market Activities in the EU-MDR
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