Finding out the true potential of your business, together.
About QARA Solutions
Amar Chanani
Medical Device Consultant
Amar Chanani is the founder of QARA Solutions, LLC, offering practical and efficient Quality Assurance and Regulatory Affairs consulting and services to medical device manufacturers.
Amar’s background is in designing and implementing ISO 13485 and 21 CFR 820 based Quality Systems and Regulatory Affairs processes, including Supplier Quality, CAPA, Training Management, Risk Management, Advertising & Promotional Materials, Product Labeling, Regulatory Intelligence, Regulatory Information Management, and State Licensing.
Amar has also worked in Engineering and Operations for medical devices, aerospace, and automotive manufacturers and suppliers, in new product development, sustaining engineering, and manufacturing.
Amar holds a Master’s Degree in Bioengineering, as well as Bachelor’s Degrees in Mechanical Engineering and Economics, from the Georgia Institute of Technology. Additionally, Amar has a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS), is a Project Management Professional (PMP), and is a Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Software Quality Engineering (CSQE), Certified Reliability Engineer (CRE), Certified Quality Engineer (CQE), and Certified Quality Auditor (CQA) from the American Society for Quality (ASQ).
Our Approach to Medical Device Consulting
At QARA Solutions, we believe that effective business development in the medical device industry requires a deep understanding of regulatory requirements, quality standards, and market dynamics.
QARA Solutions is a consulting service for Regulatory Affairs and Quality Assurance of medical devices. We focus on providing quality and regulatory services to manufacturers of low-to-medium risk devices (i.e. Class I and II). We take a practical approach to managing risk and maintaining compliance, appropriate for your company's products.
We are dedicated to providing top-notch services. With a focus on excellence and quality, we strive to exceed our clients' expectations. We are passionate about making a difference in the healthcare industry and helping our clients bring safe and effective medical devices to market.​