Tawney Schwarz's Contact Details

Tawney Schwarz's Company Details

Quality Solutions & Support

Holland, MI, US • 5 - 9 Employees
Management Consulting

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 13485Upgrading ISO 13485 to the Medical Device RegulationUpgrading Quality System from ISO 13485 to Health Canada RegulationsSupport Services for USFDA 21 CFR part 820Gap AnalysisAuditsInternal AuditsVendor / SupplierWritten responses to FDA Form 483's and Warning LettersInspection Assistance and Follow-upManagement ReviewPreparation and Submission of 510(k)'sPreparation and Submission of Technical FilesWriting Standard Operating Procedures (SOP'S), Forms and Work InstructionsDevelopment of Device Design History FileSupport Center for Open Payment / Sunshine Act ComplianceDevelopment of procedures and forms for proper Current Good Tissue Practices (CGTP) as directed by FDA 21 CFR part 1270 and 1271 - Tissue DistributionQSS 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.