Quality Solutions and Support

quality solutions and support (qss) is a us veteran owned 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 (mdr) requirements. 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 regulation 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 warning letters inspection assistance and follow-up management review preparation and submission of 510(k)’s preparation and submission of technical files writing standard operating procedures (sop’s), for