SARACA Solutions is announcing the addition of Samuel Wade as senior vice president of business development for North America.
“Sam improves the strengths of SARACA Solutions in the medical device regulatory and quality assurance areas where there’s constant changing and growing demands on the industry,” said Kuldeep Tyagi, CEO and managing director of SARACA Solutions. “We look forward to increasing the North America business in this area as well as other aspects of outsourced engineering and R&D. His wealth of experience will be a strong benefit to our current and potential customers who strive to navigate these issues in order to keep marketing their products and services in various global geographies.”
Wade has worked for both small and large medical device companies for more than 40 years, including
Boston Scientific, the former St. Jude Medical and Becton Dickinson. He has been involved with operations, quality management systems, regulatory authorities issuing resolutions and remediations, device clearances and international registrations in the U.S., Europe, South America and Asia Pacific. In addition, he has led external regulatory audits and inspections, directed supplier quality assurance programs, and managed manufacturing outsourcing efforts.
“I’m looking forward to working closely with the SARACA Solutions team and customers. Managing medical device quality and regulatory issues requires vigilance and organized efforts within company,” Wade said. “The rules are sometimes challenging to interpret and require expertise to make certain the right documentation and responses are effectively and efficiently maintained. All this to avoid the risks not only to the health and safety of patients but the company as well as they strive to continue marketing in all approved locations.”
ABOUT SARACA SOLUTIONS
SARACA Solutions, founded in 2014, is a leading international engineering services company providing
solutions and services in quality, regulatory, mechanical engineering, and open source software development for the medical device industry. The company is based in New Delhi, India, with a location in Fair Play, SC, United States. Our technical and service capabilities range from complete end to end solutions to special requirements for medical OEMs and service providers.
SARACA offers consultancy services to the medical device and diagnostics industries including:
Mechanical and embedded engineering design meeting global regulatory standards – US FDA, EU MDR, EU IVDR, ISO 13485, TGA, 21 CFR Part820, ISO 62304 and ISO 14971.
Implementation of new regulations, including the EU MDR and IVDR and creation of CERs and PERs and strong clinical practice supporting EU requirements, providing strategies and turnkey approach to completion of CERs, PERs, and PMS-related deliverables including PSUR, PMCF/PMPF plans and reports, PMCF/PMPF surveys.
Full-service suite of regulatory and quality solutions, including regulatory strategy and submissions, quality systems, safety risk management, and process validations.
Regulatory finding response management, providing best practice strategic, tactical, and creative solutions to address NB nonconformity reports, as well as FDA 483 findings, warning letters, and consent decrees, with a highly scalable team for remediation programs.
Our service-oriented team of regulatory and clinical experts, engineers and designers possess extensive medical industry experience and has a keen understanding of the challenges faced by modern medical device companies. This understanding helps SARACA provide cost-effective customized solutions for market segments including Orthopedic, Cardiology, Medical Software, Neuromodulation, Radiology, Surgical, Imaging Systems, Remote Patient Monitoring, and Laboratory Equipment. SARACA Solutions also has expertise in the Aerospace, Defense, Rail and Transportation industries. Learn more by visiting www.saracasolutions.com or email [email protected]
For more information, contact:
Kevin J. Berger, Head of Marketing
Kuldeep Tyagi, CEO and Managing Director