Tracy Omdahl Email & Phone Number

Worldwide

I am in business to provide our clients with a world-class service experience that assures them and their stakeholders that their products are brought to market expeditiously and are of the highest quality through a quality system that is compliant and efficient.

Wordwide Internet

Develop and maintain custom cloud-based Quality Management Systems virtually located entirely in Google Drive.

Worldwide

Long term successful CEOs do not hide behind false reports for hire. CEOs welcome being self-cleansed with potent assessments. CEOs need incorruptible tough love and to be challenged by stiff, deep dive, super-thorough, high-bar assessments from fearless and knowledgeable quality policemen in order to help get them out of the high risk profiles. Other registrars and internal auditors obviously can't give that to us due to their many vested interests. They soft-grade nonconformities for fear of the consequences of reporting truth. There remains an under-served market for honest and firm assessments not held back by obscuring lies. Quality Police fills this void for medical device, IVD, and pharmaceutical markets.╬═══╬═══╬═══╬═══╬═══╬» QMS STRESS TESTReveal weaknesses before outsiders find them.» for HRIs your staff competent?» for INVESTORSIs the company equipped and staffed to make compliant products?» FORENSICSWhat is the real root cause?» REMEDIATESolve FDA Warning letters, CE Major noncompliances, Suspensions» AUDITThorough appraisals. Meaty high-bar world-class audits with real findings that challenge your system and identify faults. Audit findings to get better. A punch list that will get you somewhere. Be assessed by an expert, not an inexperienced amateur wasting your time to crank out a meaningless report that does nothing for your company.» PROTECTPrevent. Don’t remain open, exposed, and totally unprotected even after you think all corrections are taken.» CHANGEQuality Police was formed to ARREST your nonconformities.╬═══╬═══╬═══╬═══╬═══╬▓ 43 years constantly in the assurance field▓ Expert in ISO13485, CFR, cGXP, MDR (CE), IVDR, CMDCAS, and Remediations▓ Internationally certified medical device assessor▓ Health Canada Certified Medical Device Assessor▓ Registrar medical devices assessor▓ Fluent in English & Spanish▓ Assessed and consulted in 29 countries.▓ Former US Government Quality Assurance Representative

Compliance with MDSAP, 21CFR801, 803, 806, 807, 809, 811, 820, 830, 11; ISO 13485, CMDCAS, MDR, IVDR, AIMDD and others.

Assessor to 21CFR820, ISO13485, Canada MDR, Combination Product and others.

Lead Auditor

Reliability Engineering of Kidney Dialysis Machines, Insulin Pumps, Blood Sugar Monitors, Missile Targets, Nuclear Assets, Telecommunication Equipment, GM Trucks.

Compliance with ISO13485, MDD, CMDCAS, AIMDD, IVD, CFRs

Reliability of Transmissions, Clutches, Computer Controllers.

Engineering

Activities and Societies: US Army Karate Team, Debate Council and Forum, Century man, Turnback from ‘77 to ‘78, Commandant’s list ‘75.

Council On East Asian Studies, Japanese Commerce, Certificate

Professor, Assurance Sciences

Ft. Sam Houston, Us Army

USAADATT - Unites States Army Alcohol and Drug Abuse Team Training

Associate Director Of The Reliability Engineering And Management Institute

Business Administration And Management, General

Bachelor Of Science (Bs), Physics, Math, Spanish

Member of US champion intercollegiate boxing team.