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Our Team

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Orlando Banos
President and CEO 
With 23 + years of professional experience in quality assurance, regulatory, manufacturing, engineering, and product development with a heavy focus on quality management to ensure that products (and services) are developed (designed), manufactured, tested, and delivered according to established procedures that will assure compliance and continuous improvement.  
I have worked for some of the biggest companies in the medical device, pharmaceutical and consumer
products industry on a global scale. Such companies as Medtronic, Boston Scientific, Becton-Dickinson, Kimberly-Clark, Cordis Corporation, a previous Johnson & Johnson company, Zimmer Biomet, Cook Medical and Arthrex. Specializing in remediation efforts of quality systems associated with corrections, improvements, validations, training, coaching, CAPA files/records, design controls, risk management and much more. I am also fluent in Spanish can speak, read and write. 
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Chris Pugh
Sr. Quality Consultant
With over 23 years of experience in the Medical Device, Pharmaceuticals, and Automotive Mr. Chris Pugh specializes in Quality Management Systems, Production and Process Controls, Environmental Controls, creating compliance to: ISO 13485,  ESD S20.20, ISO 14971 and 21 CFR Part 820. Extensive experience  with FDA Warning Letter responses, Consent Decree remediation and planning, Remediation/Work-Stream Lead, V&V and CAPA remediation. 

 

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Dallas L. Thomas
Sr. Regulatory & Quality Consultant
Mr. Dallas Thomas brings years of experience in the areas of regulatory affairs, quality management systems, compliance, and auditing (such as MDSAP). He has worked on activities associated with maintaining regulatory approval, compliance to ISO standards, FDA, and European regulations among other international market authorizations of products. Mr. Thomas also brings exposure to national & international regulatory standards such as the new EU Medical Device Regulation (MDR), EU TPD 2014/40 EU, Good Manufacturing Practices (GMPs), ISO 13485, ISO 9001, Quality Systems Regulation (QSR), 21 CFR part 820, Food Drug and Cosmetics Act, RDC 185 (ANVISA in Brazil), EU MDR 2017/745, Clinical Evaluation Reports (CER) per MEDDEV 2.7/1 and Latin America regulations. He also bring his multilingual skills to our team, as he is fluent in Portuguese and Spanish. Mr. Thomas holds certifications from Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society, Certified Lead Auditor for ISO 13485 issued by BSI and Certified Six Sigma Yellow Belt.

 

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Maritza Zayas
Sr. Quality Consultant
Mrs. Maritza Zayas has 30 + years of experience in a regulated and highly structured manufacturing environments, which have been governed by such regulatory bodies as FDA, FAA, ISO and Aerospace standards. Mrs. Zayas has demonstrated strong leadership skills with extensive track record with contributions to increased production, quality, profitability, customer satisfaction and cost reduction effectiveness. Mrs. Zayas holds certifications from RABQSA Certified Lead Auditor ISO 13485, ASQ Biomedical Auditor, CAPA expert, QMS SME, Team Building & Leadership and Quality Assurance & Compliance Audits.
 

 

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