Episode 10 – Understand MDSAP with Angelina Hakim
On today’s show, I invited Angelina Hakim the CEO of Qunique which is an Agency helping customers on Regulatory projects and also provide some service as an auditor.
She has 12 years of experience in Medical Devices with manufacturers and consulting organization. She is MDSAP and ISO 13485 certified.
MDSAP stands for Medical Device Single Audit Program and this is a new way to get certified for companies that are selling products to the USA, Australia, Japan, Canada, and Brazil.
This is a recent program that helps manufacturers to get audited only once instead of many times by each organization.
Below was an infographic I created for one of my article on my blog Easy Medical Device.
QUNIQUE provides medical device companies with customized solutions for quality management systems (QMS), supporting the implementation of new processes and training personnel appropriately.
QUNIQUE focuses on compliance and efficiency. Its services cover the whole range, from creating a template or a standard operating procedure (SOP) to implementing a full QMS in compliance with ISO 13485:2016, Medical Device Single Audit Program (MDSAP), US Food and Drug Administration (FDA) 21 CFR part 820, or ISO 9001:2015.
QUNIQUE understands the regulatory requirements for medical device manufacturers, including the EU medical device regulation (MDR), MDSAP, and the ISO 13485:2016.
Qunique website: https://www.qunique.ch
Easy Medical Device Article: https://easymedicaldevice.com/mdsap