Yon Cole

About Yon Cole

Bringing a wealth of knowledge and resources to medical device companies: Scalable: Training, Systems, Solutions for ISO 13485 compliant Quality Management Systems.(Leveraging proven SOPs, Customization, Training, Implementation): Doc Control, Design Control, Supplier Evaluation, IQ/OQ/PQ, Maintenance & Calibration, Receiving/Inspection, Nonconforming Material, Complaints/MDR/Vigilance Reporting, CAPA, Management Review, Internal Auditing, process development, process validation. Facilitate or Train for ISO 14971:2019 Risk Management Systems (Hazard Analysis/Risk Assessment/FMECA) to maximize value added through early concern identification. Full Regulatory Assessments and streamlined value added implementation of compliance strategies for all applicable standards, guidance documents, and harmonizations. EU MDR/Eudamed/UDI/GS1 Med Dev UDI requirements International: Australia, Brazil, Canada, Egypt, Saudi Arabia, Sinapore ISO 13485/ 21 CFR 820 Quality Management, ISO 14971 Risk Management, EN IEC 60601-1 Medical Electrical Equipment, EN IEC 60•••12 EMI/EMC, EN 60•••16 / IEC 62366 Usability, EN IEC 62304 Software, EN 1041 / AIMD+MDD Essential Requirements/ 21 CFR 801 labeling, EN 45502-1 / ISO 14708 / AIMD / FDA Class Active Implantables, MDD & Essential Requirements/ 510k FDA Class II special controls, ISO 10993 Biocompatibility, EN ISO / EN ISO ETO/Gamma Terminal Sterilization, Class Cleanroom/Controlled Environment/Bioburden monitoring, ASTM D 4169 Packaging, MIL-STD-883, MIL-PRF-31032 HIPAA, OHSA, Exposure Control Plan, PPE, Bloodborne Pathogens, Hazardous Materials & DoT, EN 62133 Li-Ion batteries, IEC 60529 Degrees of Protection by Enclosure (IPXX), ISO IEC 17050 Declaration of Conformity Additional: Design Input Reliability Testing / Accelerated Life Testing Hermetic Assembly/Seal/Internal Moisture Statistical Techniques Data Systems (Mfg/part data databases) Training (Team, Subject Matter Areas, Skills & Professional) Exceptional command of Microsoft Applications

Experience

1. Self

   Nov 2016 — Present · Las Vegas, NV, US

   Self Employed - Quality Management & Regulatory Consultant [Las Vegas, NV][Nov 2016 – Present]Provide custom compliance & business solutions to small businesses in the medical device sector; areas of focus: EU MDR compliance, Technical Documents/Design Dossier review & update, Risk Management review, Risk/Benefit Analysis, Clinical Evaluations, Post-Market Surveillance, Post-Market Clinical Follow Up, Post-Market Periodic Safety Update Reports, Labeling/IFU review, ISO 13485:2016 QMS compliance, 21 CFR 820 compliance, SOP/Quality Manual/Work Instructions updates, ISO 14971 Risk Management process support, 3rd Party Internal Audits, Standards compliance support for EN IEC 60601, IEC 62304 software, IEC 62366 Usability & Human factors, regulatory audit support, post-audit implementation of improvements based on observations, supplier contract review. Corporate compliance & Operations Insights support.• EU MDR compliance: including UDI and Eudamed• Successful business ownership transition, with corporate compliance & operations back on track.

Education

• University of Minnesota

  Bachelor of Science - BS

  1999 — 2003

• Eastview Senior High School

  Diploma

  1997 — 1999

• Southern Methodist University

  Masters

  2003 — 2006