My Story:

Michael has over twenty-five years of Systems Design/Manufacturing in Highly Regulated Industries such as Medical Devices, Pharmaceutical, and Aerospace. Michael’s diverse technical and business experiences contribute to his successful delivery of business outcomes for clients. His application of problem-solving methodologies from the Lean Six Sigma and PMI communities provides increased resource productivity while delivering technical results with high quality documentation.​

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Michael brings extensive experience with developing, communicating, and executing multiple project plans into integrated Programs that achieve multiple business objectives using cross functional resources. He brings leadership qualities to his programs without disrupting the organizational culture during the change process.​

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Michael’s Life Science projects/programs have been successful despite challenging conditions such as FDA 483 Warning Letters, FDA Consent Decrees, Changing Compliance Standards (IEC 60601, ISO 14971, IEC 62366, IEC 62304), and Evolving Regulatory Expectations (US 510k/PMA, EU MDD to EU MDR, and Software as a Medical Device-Cybersecurity).​

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Some examples of delivering results under challenging conditions:​

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• Led the successful remediation of pharmaceutical steam cleaning validation to satisfy a 483 Warning Letter​

• Led the successful remediation/closure of medical device Maintenance/Calibration CAPA - 483 Warning Letter​

• Led successful medical device program/projects submitting multiple US 510k’s under US Consent Decree (+ closed CAPA’s)​

• Led successful remediation of 20+ EU MDD product families to comply with EU MDR QMS and TD compliance​

• Led multiple life science design/technical transfers to manufacturing, distribution, and commercialization (Healthcare/Retail)​

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Contact Me:

I'm always looking to meet new people to network and collaborate.

averionm@outlook.com