Responsable Sanitario for COFEPRIS, medical devices manufacturer.
Experience on COFEPRIS GMP certification for medical devices.
Experience on ISO 13485 QMS Certification.
Regulatory requirements FDA as: 21 CFR Part 820 (GMP), Part 803 (MDR), and other related regulations.
Mexican regulations: NOM-240-SSA1-2012, NOM-241-SSA1-2012, NOM-137-SSA1-2008.
ISO 14971 (Risk Management for Medical Devices).
Process and Software validation.
Speciality on Injection Molding Process.
Assembly Process.
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