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Integrated Quality Management System

Experience seamless quality control with our Integrated Quality Management System. Elevate efficiency and productivity effortlessly. The QMS requirements of the Canadian Medical Devices Regulations are included in the MDSAP. A document outlining the current good manufacturing practices requirements is the FDA 21 CFR Part 820, often known as the Quality System Regulation. A MAVEN integrated quality management system complies not only with ISO 13485, but additional medical device regulatory requirements in many other markets.<br>

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Integrated Quality Management System

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  1. INTEGRATEDQUALITY MANAGEMENT SYSTEM www.mavenprofserv.com

  2. OVERVIEW Introduction Canada-QMSrequirementsformedicaldevicecompanies MDSAPandHealthCanada USAQMSrequirementsformedicaldevicecompanies MDSAPandUSFDA HowmavenhelpyouinIntegratedQualityManagement System?

  3. Introduction An IntegratedManagementSystem(IMS)integrates all of an organization’s systems and processesintoonecompleteframework, enabling an organization to work as a single unitwithunifiedobjectives.Experience seamlessqualitycontrolwithourIntegrated QualityManagement System.Elevateefficiency andproductivityeffortlessly.

  4. Canada-QMSrequirementsformedicaldevice companiesd UnderMDSAP, manufacturersofClassII,III,andIV medical devicesmustdemonstrateISO13485compliance.TheQMS requirementsoftheCanadianMedicalDevicesRegulations(CMDR) areincluded intheMDSAP. Before your devicecan be sold in Canada,aHealthCanadaandMDSAP-accreditedAuditing Organization(AO) mustcertifyyourMDSAP-compliantquality system.AsofJanuary1,2019,MDSAPcomplianceismandatory.

  5. MDSAPandHealthCanada As part of their Canadian Medical Device Conformity Assessment System (CMDCAS) accreditation programme, Health Canada will conduct an MDSAP audit. Upon the successful completion of the pilot, Health Canada intends to establish the Medical Device Single Audit Program as a means to achieve regulatory compliance for qualitymanagementsystemrequirementsinCanada.

  6. USAQMSrequirementsformedicaldevice companies A document outlining the current good manufacturing practises (CGMP) requirements is the FDA 21 CFR Part 820, often known as the Quality SystemRegulation(QSR).Thisdocumentoverseesmanufacturing processesto guaranteethattheirgoodscomplyconsistentlywith applicablespecificationsandregulations.Thequalitysystemapproved by the FDA is FDA 21 CFR Part 820. These guidelines are designed to assure safe and effectivemedicaldevices.Medical devicemakers to ensurecompliancewithFDA21CFR820conductFDAinspections.

  7. MDSAPandUSFDA FDA will accept the MDSAP audit reports as a substitute for FDA routineinspections.Inspectionsconducted“forcause”or “compliancefollow-up”byFDAwillnotbeaffectedbythis program. Moreover, the MDSAP would not apply to any necessary pre-approval or post-approval inspections in support of Premarket Approval(PMA)applications.

  8. HowMAVENhelpyouinIntegratedQuality ManagementSystem? MAVEN specializes in medical device regulatory compliance. Ourconsultantshaveassistedmedicaldevicecompanies worldwidewithISO13485QMSintegrationwith21CFRand MDSAP. A MAVEN quality management system complies not only with ISO13485, butadditionalmedicaldeviceregulatory requirementsinmanyothermarkets.

  9. InadditiontoISO13485consulting,wecanassistwithmedical devicelicensesandestablishment licensinginvarious countries.

  10. ContactUs https://mavenprofserv.com/integrated-quality-management-system/ business@mavenprofserv.com enquiry@mavenprofserv.com

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