Saraca Solutions is a leading a Medical Design Engineering Services company with niche focus on Mechanical Engineering, Quality, Regulatory and Open Source software Development. Our technical and service capabilities range from complete end to end solutions to special requirement for Medical OEMs and Service providers.
Our mechanical and embedded engineers have strong technical backgrounds on Design, Engineering and global regulatory standards - FDA, CE, MDD, ISO13485, 21CFRPart820, ISO62304 and ISO14971.
To provide best-in-class customer service through our quality of the work and patient listening to the needs of our customer.
Achieve success in helping our customer's business grow faster and enabling them lead in the industry they serve.
Kuldeep is managing director of saraca solutions and medical device professional with 17+ years of experience in design, development, quality, and regulatory of medical devices and healthcare products.He has successful track record of building new services from inception and making them sustainable and high performing businesses by implementing strong management and leadership best practices backed with strong systems, processes and controls.
Previously he was global head of medical business unit at Cyient where he set-up Medical Practice almost from scratch and transformed it to a fully grown business unit in 4 years with revenue of $10M. He has also worked with TCS and started a new delivery center for Medical business in Delhi and established capabilities in segments like spine, cardiovascular, TKA additive manufacturing instrumentation and remediation
He has worked in Chicago & Minneapolis, USA for 5 years and travelled for business globally in countries including Germany, Netherlands, South Korea, Sweden, Denmark, Dubai and Japan.
He is Bachelor of Engineering, Production and Industrial from MNNIT, Allahabad and PMP@Certified professional from Project Management Institute, USA since 2008
He has two USA and Europe patents granted for his innovation:
SPINAL ROD CONNECTOR - Europe EP1884212A1 & US D643925 S1. Learn More
UHF RFID Tag for Medical Systems - US 8690068 B2. Learn More
He has 6 patents pending at various stages for his innovations.
He has published 50+ White papers, articles, conference papers globally including Quid pro quo healthcare – Financial Express, UHF RFID re – Tata Management Training Center. Here is the list of his recent publications:
PM Networks - Global Magazine by PMI, USA: 3D Printing - The 3D Printing Revolution is pushing Project
Managers in creative new dimensions. Page 65. Learn More
MPO Magazine - Global Medical Product Outsourcing Magazine: When Off-the-Shelf Components are not Enough. Learn More
Financial Express - Quid pro quo healthcare: Learn More
Medical product development engineering executive with strong creativity, leadership skills and broad industry knowledge in orthopedic, spinal, otology and ophthalmic markets.
Key areas of expertise include: Global Design Control, IP Management, Surgeon & Consultant Management, Technology Assessment & Integration, Product and Portfolio Management, Strategic Planning, Regulatory Strategy, Managing Multinational Teams, Cross Functional Leadership, Team Building and Problem Solving.
MBA, 1986 - 1988
MS, Biomedical Engineering, 1978 - 1980
BS Mechanical Engineering, 1974 - 1978
A Bioengineering Inventor, Innovator and Design thinking expert. Trained in Stanford Biodesign Program in 2013, he designed and licensed out a nationally awarded biomedical device Thorashield, a safer pleural tapping technology. He is a recipient of Jamsetji TATA, Ratan TATA and Johnson & Johnson COSAT Grant awards.
His area of expertise includes finding unmet clinical needs, orthopaedic biomechanics, orthopaedic product development, low cost innovation and medical device production management.
MS Biomedical Engineering (2014-2015)
Stanford-India Biodesign Program (2013)
B.Tech Biotechnology (2006-2010)