Our Mission
"qualiroo's mission is to empower SaMD companies deliver better patient care by providing Q&R expertise and smart, sleek solutions."
About Us
Our team works together with you, and can remain embedded within your organization for as long as needed. Contrary to most other consultancies, we do not offer services across the spectrum of Medical Devices. Instead, we offer niche services in the field of Software as Medical Devices.
All services are provided remotely, reducing carbon footprint, and cutting costs for clients, allowing them to spend their money on other important activities.
We are experienced Quality and Regulatory professionals with expertise in the Software as a Medical Device.
Aastha has a Bio-Medical Engineering background and has completed a Masters of Science degree in Regulatory Affairs from Northeastern University, USA. She has worked at several Medical Device companies and stepped into the world of Software as Medical Devices in 2012 when such devices were still in their initial phases. She has experience handling the FDA, TGA, EU Notified Bodies, and several Certification Bodies.
She has also been involved in filing of several 510K and De-Novo submissions for different client companies. She has extensive experience in implementing Quality Management Systems for start-up companies and acting as the Q&R Representatives for them until they are ready to handle the work on their own.
To enhance her knowledge in the field of Artificial Intelligence and Machine Learning, she has completed a certificate course in Designing and Implementing AI solutions for Healthcare from Harvard Medical School Executive Education.
She has held ASQ Certified Quality Auditor Certification since 2012 and has recently gained ASQ Certified Medical Device Auditor credential.
Having been in the Medical Device Industry for more than 13 years, she understands the importance of doing things right at the first time and helps her clients to achieve the certification and maximize their potential to get regulatory approvals, the first time.
