Our Commitment to Quality
Strong qualifications are critical when consulting for a medical device company pursuing ISO 13485 certification. With an average of 15 years of experience building and auditing Quality Management Systems—and a perfect record of successful FDA and ISO audits—TQS offers our clients proven, practical expertise. All TQS consultants are certified by Exemplar Global as ISO 13485 Medical Device Lead Auditors and ASQ CMQ/OE certification further validating our ability to interpret requirements, lead organizations through compliance, and ensure audit-ready systems grounded in industry best practices.
Services
Regulatory
Leveraging over 15 years of experience as senior quality and regulatory leaders in the medical device industry, we help companies strengthen their Regulatory Affairs function by ensuring full compliance with FDA 21 CFR 820, ISO 13485, and global regulatory requirements. we provide expertise in design controls, risk management, audit readiness, CAPA, and QMS implementation—whether building systems from the ground up or optimizing those in place. With a proven track record of securing regulatory clearances, achieving flawless FDA/ISO audit outcomes, and guiding cross-functional teams, our team support medical device innovators in bringing safe, compliant Class II/III products to market efficiently and with confidence.
Consulting
We help companies achieve fast, audit-ready ISO 13485 certification by building, implementing, and optimizing end-to-end quality management systems. Our team brings a proven record of 100% FDA and ISO audit pass rates, deep expertise in design controls, risk management, CAPA, supplier qualification, and process validation, and hands-on success guiding both start-ups and multinational organizations through certification and regulatory readiness. Drawing on our background as Exemplar Global certified ISO 13485 lead auditors and our experience implementing QMS frameworks across multiple international sites, TQS provides practical, scalable solutions that ensure compliance, improve operational efficiency, and accelerate time to market
Auditing
We offer thorough third party and internal audits to ensure compliance with FDA and ISO standards. Let us handle your supplier audits or be an impartial internal auditor.
Support
TQS offers fractional quality management and ongoing support and guidance to maintain your compliance status and optimize performance.
