About OVA Solutions

OVA Solutions is a medical device engineering firm that takes products from concept through regulatory clearance to manufacture.

Quality system

OVA Solutions belongs to the same group of companies as Canyon Medical Inc. Our engineering work runs under the group’s ISO 13485:2016 certified quality management system: certificate No. 044-25, issued by Improve Medical LLC, valid until October 13, 2028, scope “design and development, production and distribution of medical device prototypes”.

Leadership

Lisa Voronkova is a medical device development expert and CEO of OVA Solutions, a medical device engineering firm. She holds a PhD in applied mathematics and is the author of Hardware Bible: Build a Medical Device from Scratch, a practical guide to taking a device from concept to a cleared, manufacturable product. She writes about the regulatory, engineering, and commercial realities of the industry for Medical Design & Outsourcing, MD+DI, and her newsletter No Mercy MedTech.