QES Medical LLC

medical devices

About

QES Medical LLC is a consulting firm established in 2009, focusing on quality, regulatory, and software development consulting services for the medical device and pharmaceutical industries. The company assists clients in achieving and maintaining Quality Management System (QMS) certifications, software life cycle processes, and compliance with current Good Manufacturing Practices (cGMP) and product regulatory requirements. Their services include consulting and training on Quality Management Systems, regulatory consulting for product clearance, software development compliance, risk management, and usability compliance. QES Medical also offers tailored consultation services and training sessions on various topics, including audit readiness and design control processes. They serve a diverse range of clients, from small businesses to large corporations, ensuring that their services meet specific client needs. Based in the Greater Boston Area, QES Medical LLC is dedicated to helping companies navigate regulatory challenges and maintain high standards of quality and compliance.

Technologies

Gmail Google Apps Google Cloud Hosting Facebook Login (Connect) Facebook Custom Audiences Mobile Friendly Wix Varnish Facebook Widget Gusto Webmail Node.js IoT Android Render Highspot Micro Data Analytics Circle Remote

Keywords

usability compliance per iec 623661 iso 13485 fda qsr 21 cfr part 820 audit readiness preparation risk management quality management systems design control iso 14971 design & development medical device software compliance per iec 62304 regulatory affairs services regulatory strategy for market entry regulatory documentation review for medical devices regulatory strategy development quality system implementation quality culture technical documentation assessment b2b medical devices electronic qms platforms regulatory guidance services eu mdr compliance audit support services healthcare pharmaceuticals fda qsr 21 cfr regulatory consulting services software lifecycle processes regulatory documentation

Location

Boynton Beach, Florida, United States, 33437

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