New medical device and pharma leader brings more than 15 years of experience in field for SARACA Solutions customers and prospects
Online PR News – 23-February-2021 – NEW DELHI – SARACA Solutions is announcing the addition of Ankur Aggrawal as associate vice president for its medical device and pharmaceutical engineering services business. He has more than 15 years of experience in complex design and development of medical devices, including orthopaedic and cardiology implants and instruments, hospital infrastructure equipment, electromechanical products, and in-vitro diagnostics.
“We welcome Ankur to our team,” said Kuldeep Tyagi, CEO and Managing Director of SARACA Solutions. “He brings strong value to our current and growing customer base that we are looking forward to develop as our organization continues to grow. Ankur has extensive experience managing on behalf of
clients all aspects of the medtech product lifecycle that continues to become more complex with changing and challenging worldwide compliance and other marketplace issues.”
Aggarwal has led new product development programs starting from concept design through verification and validation. He has successfully handled external audits of ISO 13485. In his past roles with Cyient and Tata Consultancy Services, he has worked with many large medical device companies, including
Becton Dickinson, Medtronic, Philips, GE Healthcare and Smith & Nephew.
“SARACA Solutions has a growing team that’s really looking to make a mark for innovation and provide effective services to both small and large medical device firms,” said Aggarwal. “Our teams are energized as extensions of these companies that make a difference in the lives of patients around the
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 http://www.saracasolutions.com or email firstname.lastname@example.org.
For more information, contact:
Kevin J. Berger, Head of Marketing
Kuldeep Tyagi, CEO and Managing Director