Responsibilities Support the implementation of a new QMS per the requirements of FDA 21 CFR Part 820 and ISO 13485:2016. Activities...

Responsibilities Accountable for compliance to FDA 21 CFR Part 820, ISO 13485:2016 and other applicable regulatory requirements for the...

QES Medical LLC will attend the BIOMEDevice Conference on SEPTEMBER 21-22, 2021 at the Boston Convention & Exhibition Center in Boston,...

Free QMS Overview Webinar, June 17th, 2021. RSVP at www.qesmedical.com https://www.linkedin.com/posts/oscargarciaqesmedical_webinar-quali...

On April 26, 2021, the FDA announced the decision to conclude the "Quality in 510(k) Review Program Pilot". After May 30, 2021, the FDA...

This is a question all start-ups, as well as existing companies, must answer correctly. I recommend the following FDA's CDRH Learn...

I found this FDA's resource page very interesting and straight to the point. In addition to following these recommendations, I think it...

When it comes to implementing and maintaining risk management for medical devices, you likely face the same challenges as many companies....

When looking at the cycle of maintaining your Quality Management System (QMS), you face the same challenge as many companies. You go...