About Us

Sharmini Atheray, the founder of Medical Device Advice, Inc., has over 25 years of experience with Medical Devices, Over-The-Counter Drugs and Natural Health Products.  Previously, Ms. Atheray was the Vice President of Global Quality Operations and Regulatory Affairs with a leading Medical Device company. 

Her expertise includes: 

● Clinical Evaluation Report Writing 

● 510(k) preparation and submissions

● Emergency Use Authorization Submissions  

● De Novo request submissions

● Pre-Submissions (Pre-Subs)

● Submission Issue Requests (SIRs)

● 513(g) Requests

● CE technical file /design dossier preparation

● All aspects of sterilization techniques

● Implementation of the quality management system in compliance to the Canadian Medical Device Regulations (SOR/98-282),   21CFR Part 820 Quality System Regulation, ISO 13485:2016/MDSAP and Medical Device Regulation (EU) 2017/745.

● Labeling compliance for Medical Devices and Over-The-Counter Drugs

● Establishment Registration and Device Listing of Medical Devices with the FDA

● Medical Device Establishment Licensing and Medical Device Licensing with Health Canada

● Registration of Natural Health Product with Health Canada

● Cosmetic Notification 

● Due diligence and supplier audits

Ms. Atheray, holds a Master of Science degree and a Bachelor of Science degree  in Microbiology from the University of Rhode Island and is a Certified Quality Auditor with the American Society for Quality.  

Under the leadership of Ms. Atheray,  Medical Device Advice, Inc., provides custom-tailored consulting services to match your needs with precision and accuracy.  Our primary focus is to help you achieve and maintain regulatory compliance, increase quality awareness and expedite time- to- market at a very affordable price.