- Verification &Validation (V&V) of software that complies with FDA standards for Quality.
- FDA Regulated experience: FDA (21 CFR 211 & CFR 820) ISO 13485, DICOM, HL7.
- Successful Class II/III device and software (Major level of Concern) experience with
- In-Vitro Diagnostic (IVD), Combination Drug/Device and cardiology devices.
- Experienced in managing projects and developing software supporting Clinic and Medical devices.
- IQ, PQ, OQ for a (Nuclear Magnetic Resonance) NMR device and managed quality Initiatives.
