Sakthi Inc

Qualitas Compliance LLC is a women-owned business specializing in quality system management and regulatory compliance for the medical device industry. With a focus on helping start-up and mid-sized companies achieve the necessary quality and regulatory standards, they offer services such as quality system development, contract auditors, CAPA assistance, and certified safety testing. Their team of experienced professionals provides exceptional insight and understanding to streamline compliance and overcome regulatory challenges. Based in Morrisville, NC, Qualitas Compliance LLC serves companies throughout the USA and Canada, including the Raleigh-Durham-Chapel Hill, Charlotte, Atlanta, Tampa, Boston, and Pittsburgh areas. With a mission to assist companies in designing, manufacturing, and selling FDA-approved products, they offer expertise in ISO 13485, FDA 21 CFR Part 820, EU MDR 2017/745, and ISO 9001 compliance. Whether it's conducting gap analysis, managing risk in accordance with ISO 14971, or providing onsite training, Qualitas Compliance LLC is dedicated to helping their clients navigate the complex landscape of medical device compliance.Generated from the website