Oscar Garcia
We are growing...and hiring. Come join us!
QES Medical LLC is looking to expand its team to support new projects and we have an opening for a QA Consultant/ Design Control. Learn...
Search
Oscar Garcia
New Job Opportunity: QA Consultant / Design Control
Responsibilities Actively execute quality assurance in design development, including but not limited to: Support design control...
Oscar Garcia
What is your medical device classification?
That is an important question you need to answer for every medical device you want to bring, or maintain, in the market! I encourage you...
Oscar Garcia
How to prepare for ISO 13485 certification!
I encourage you to read the following helpful and insightful article! QES Medical LLC can help you achieve and maintain QMS certification...
Oscar Garcia
Let us help you with your Software as a Medical Device Needs!
QES Medical LLC helps medical device companies solve quality and regulatory matters, and achieve medical device software compliance. We...
Oscar Garcia
Happy Holidays from QES Medical LLC
The team at QES Medical LLC wants to wish you a happy Holiday season and a peaceful and prosperous New Year! https://www.qesmedical.com/
Oscar Garcia
Corporations no longer primarily responsible to shareholders-They're responsible to all stakeholders
I recently read the book "Good Company" by Aurthur M. Blank - Co-Founder of the Home Depot and I was pleased to read many of his...
Oscar Garcia
QES Medical strengthen position. Signs collaboration agreement w/ European Software Development Firm
NOV. 23, 2021. QES Medical LLC signs a collaboration agreement with European Medical Software Development Firm Atostek, which is a leader...
Oscar Garcia
We are growing...and hiring. Come join us!
QES Medical LLC is looking to expand its team to support new projects and we have two openings for QA Consultants. Learn more about these...
Oscar Garcia
New Job Opportunity: QA Consultant / QMS Implementation (Part Time)
Responsibilities Support the implementation of a new QMS per the requirements of FDA 21 CFR Part 820 and ISO 13485:2016. Activities...
Oscar Garcia
New Job Opportunity: QA Consultant / Site QA Leader (Full Time)
Responsibilities Accountable for compliance to FDA 21 CFR Part 820, ISO 13485:2016 and other applicable regulatory requirements for the...
Oscar Garcia
QES Medical LLC to Attend the Upcoming BIOMEDevice Conference in Boston
QES Medical LLC will attend the BIOMEDevice Conference on SEPTEMBER 21-22, 2021 at the Boston Convention & Exhibition Center in Boston,...
Oscar Garcia
Free QMS Overview Webinar
Free QMS Overview Webinar, June 17th, 2021. RSVP at www.qesmedical.com https://www.linkedin.com/posts/oscargarciaqesmedical_webinar-quali...
Oscar Garcia
Concluding the Quality in 510(k) Review Program Pilot
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...
Oscar Garcia
Is my product a medical device?
This is a question all start-ups, as well as existing companies, must answer correctly. I recommend the following FDA's CDRH Learn...
Oscar Garcia
FDA's Biocompatibility Assessment Resource Center
I found this FDA's resource page very interesting and straight to the point. In addition to following these recommendations, I think it...
Oscar Garcia
Risk Management. A Tool or a Curse?
When it comes to implementing and maintaining risk management for medical devices, you likely face the same challenges as many companies....
Oscar Garcia
Be Proactive, Not Reactive!
When looking at the cycle of maintaining your Quality Management System (QMS), you face the same challenge as many companies. You go...