Ronald Rakos
President at MedTech and RA Consultants | Springdale, Utah, United States
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Ronald Rakos serves as the President of MedTech and RA Consultants, where he leverages his extensive background in research and development engineering alongside his regulatory affairs expertise to guide medical device companies through the complexities of EU Medical Device Regulation (MDR) compliance. With a PhD in Chemical Engineering from Stevens Institute of Technology, Ronald possesses a robust technical foundation that informs his strategic approach to regulatory submissions and quality management systems.
At MedTech and RA Consultants, Ronald is instrumental in delivering comprehensive solutions for MDR Technical Documentation preparation. His role involves conducting thorough GAP analyses to identify deficiencies in existing documentation, ensuring that clients meet the stringent requirements set forth by the EU MDR. His proficiency in risk management, particularly in accordance with ISO 14971, allows him to effectively assess potential hazards associated with medical devices, thereby enhancing product safety and efficacy.
In addition to his regulatory expertise, Ronald is adept in verification and validation (V&V) processes, biocompatibility assessments, and labeling requirements, which are critical for successful market entry. His experience as an ISO 13485 Quality System assessor further underscores his commitment to maintaining high-quality standards in medical device manufacturing. Ronald's strong leadership and technical skills enable him to guide teams through the complexities of compliance, ensuring that clients not only meet regulatory requirements but also achieve operational excellence. His dedication to fostering innovation in the MedTech sector positions him as a trusted advisor for companies navigating the evolving landscape of medical device regulations.
President at MedTech and RA Consultants in September 2021 to Present
Regulatory Affairs Fellow at AtriCure, Inc. in August 2019 to August 2021
Training and Development Lead for Vascular Experts at BSI in June 2017 to August 2019
Vascular Expert Team Global Manager at BSI in March 2009 to June 2017
Vascular Medical Device Product Specialist at BSI in April 2007 to March 2009
Director, Research & Development at Prescient Medical in January 2005 to January 2007
Principal Development Engineer at Boston Scientific in January 1997 to January 2005
Senior Developemnt Engineer at Cordis a Johnson & Johnson Co. in January 1995 to January 1997
Senior Development Engineer at Cordis a Johnson & Johnson Co. in January 1995 to January 1997
Manager, Computations Group at Polymer Processing Institute in January 1989 to January 1995
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Medical Devices
Quality Systems
ISO 13485
ISO 14971
CAPA
Product Launch
Design Control
CE marking
Catheters
Stents
Validation
Quality System
Biomedical Engineering
FDA
Regulatory Affairs
Manufacturing
Iso 9000
R&D
Quality Management
ISO
GMP
V&V
ISO 9000
ISO Standards
Research and Development (R&D)
U.S. Food and Drug Administration (FDA)
Verification and Validation (V&V)
Corrective and Preventive Action (CAPA)
Quality Auditing
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What is Ronald Rakos email address?
Email Ronald Rakos at [email protected] and [email protected]. This email is the most updated Ronald Rakos email found in 2026.
What is Ronald Rakos phone number?
Ronald Rakos phone number is +15136444237.
How to contact Ronald Rakos?
To contact Ronald Rakos send an email to [email protected] or [email protected]. If you want to call Ronald Rakos try calling on +15136444237. (updated on October 30, 2024)
What company does Ronald Rakos work for?
Ronald Rakos works for MedTech and RA Consultants
What is Ronald Rakos's role at MedTech and RA Consultants?
Ronald Rakos is President
What industry does Ronald Rakos work in?
Ronald Rakos works in the Medical Equipment Manufacturing industry.
Ronald Rakos Email Addresses
Ronald Rakos Phone Numbers
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