Quality Solutions & Support

quality solutions and support (qss) is a us firm that offers a wide spectrum of quality and regulatory support. we have an award winning team that has over 38 years of collective quality and regulatory experience. qss provides assistance to companies who are in compliance with or seek to be in compliance with all fda, iso 13485 standards, health canada (cmdcas) and european union (mdd) requirements. most medical device and rad health manufacturers have experienced an fda inspection. those who have can appreciate the value of having our qualified retired fda investigator assist before, during, and after an inspection. we specialize in providing customized services based on your firm’s needs including: support services for iso 13485 upgrading iso 13485 to the medical device directives upgrading quality system from iso 13485 to health canada regulations support services for usfda 21 cfr part 820 gap analysis audits internal audits vendor / supplier written responses to fda form 483’s and