PRECISION SOLUTIONS

Precison Solutions provides support to the medical device industry. Our team at Precision Solutions has been a source of expertise since the 1985. Our team has extensive experience in overseeing Quality Assurance, Regulatory Affairs, Clinical Affairs, Clinical Support, Document Control and Project Management. The team has extensive international business experience including North America, Europe, Asia, Latin America and the Middle East... Our extensive experience includes PMA's, Humanitarian Use Devices (HUDs), 510(k)s, managing IDE's, deviolopment of clincal protocals and clinical monitoring. We provide a broad knowledge of regulatory standards including CFR, IEC, ISO, EN, NEMA, ANSI and UL... We have the experience needed when faced with an FDA audit, with 16 sucessful FDA audits. Certified as ISO lead Auditor, we have conducted over 60 supplier audits.

Also known as: Precision Solutions Consulting