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Obelix Biotech Solutions (Obelix Consulting LLC) Claimed

Pragmatic medical device regulatory and quality solutions to meet US, CA, EU compliance requirements.

Pre-Sub/IND, 513(g), 510(k)/DeNovo for CDRH/CBER, Breakthrough Services Program, Safer Technologies Program, EU Technical File/Dossier, QSR/ISO 13485 implementation/audit/remediation

June, 2023

6

Tuesday

  • 9:00 am - 9:30 am

  • 9:30 am - 10:00 am

  • 10:00 am - 10:30 am

  • 10:30 am - 11:00 am

  • 11:00 am - 11:30 am

  • 11:30 am - 12:00 pm

  • 12:00 pm - 12:30 pm

  • 12:30 pm - 1:00 pm

  • 1:00 pm - 1:30 pm

  • 1:30 pm - 2:00 pm

  • 2:00 pm - 2:30 pm

  • 2:30 pm - 3:00 pm

  • 3:00 pm - 3:30 pm

  • 3:30 pm - 4:00 pm

  • 4:00 pm - 4:30 pm

  • 4:30 pm - 5:00 pm

Timezone: America/Chicago Switch to

August 26,2019

  • Tuesday
  • 9:00am - 10:00am
  • Elisa Maldonado-Holmertz
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