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 Warning Letters Inspection Assistance and Follow-up Management Review Preparation and Submission of 510(k)’s Preparation and Submission of Technical Files Mock FDA Inspections Medical Devices Containing Radiation Emitting Devices Writing Standard Operating Procedures (SOP’S), Forms and Work Instructions Development of Device Design History File Support Center for Open Payment / Sunshine Act We offer FDA consulting services and training across a range of industries, including: medical devices, radiation emitting devices and foods. QSS has successful experience helping start-up companies develop quality management systems as well as improving those in established device firms, including outsourcing and supplier audits. We have demonstrated year after year positive results working with Notified Bodies and have guided our clients through successful audits accomplished by the FDA.