ISO Certification

ISO, EU & FDA Regulatory Affairs Consultants

ISO registration and certification consulting services for ISO 13485:2000, ISO 13488:2000 and ISO 9001 compliance, EU MDD (European Union Medical Device Directives), IVDD and AIMDD, IEC 60601-1 and IEC 61000-1 (-1, 2, 3, 4, 5, 6 & 8 ) EMC. Registration, certification and compliance certificate consultants providing assistance with FDA regulatory and notified body inspections and audits. Implementation of QSRs (FDA Quality System Regulations) and GMP standards.

EU Medical Device Directives

EU (European Union) Directives (required for medical devices) are:

  • AIMDD Active Implantable Medical Devices Directive (permanently implanted devices)
  • IVDD In Vitro Diagnostic Directive (diagnostic devices and kits)
  • MDD Medical Devices Directive (for other medical devices)

US applicability of ISO 13485 and ISO 13488

QSRs: ISO 9001 and ISO 13485 are the basis for the Quality System Regulation (21 CFR 820). Therefore, compliance with FDA Quality System Regulations (QSRs) approaches compliance with ISO 9001/ISO 13485 standards.

ISO9001 vs. ISO 13485/ISO13488:

ISO 9001 is for general industry. ISO 13485/13488 are the adaptation of ISO 9001 for specific use as a medical device quality system. ISO13485/ISO13488 place additional emphasis on:

  • Process Controls/Environmental Controls
  • Design Controls
  • Special Processes
  • Regulatory Actions
  • Traceability
  • Record Retention

Companies Listed May Have Regulatory Expertise In:

  • Registration: Submission, Notification and Compliance Certificates (independent, 3rd party consultants)
  • International Compliance:
    • Japan – PAL, MHLW and PMDA
    • Canada – Health Canada CMDCAS and CSA
    • China – CCCD and SFDA
    • Hong Kong - Department of Health
    • India – Central Drug Standards and Control Organization
  • FDA: US FDA and current GMP (cGMP) compliance, FDA QSRs (Quality System Regulations), 21 CFR Part 11
  • 510k: FDA 510(k) / Class II medical device 510k PMN submissions/notifications
  • IDE: Investigational device exemptions
  • PMA: Pre market approvals/Class III IND Applications (drugs, pharmaceutical, etc)
  • ISO Quality Systems: Quality Management Systems (QMS) consulting and training. International Standards Organization 9001:2000 (replacing ISO 9000 series 9001, 9002 and 9003), ISO 14000 series Environmental Management System (EMS), 14971:2001 (medical device hazards identification procedure) ISO TR 14969:2004: Standard for guidance for implementation of ISO13485 QMS
  • Audits: Quality system mach audit in preparation for auditing by notified bodies/auditors/accredited bodies/accredited persons (AP), internal auditor training courses.
  • Documentation: Technical Documentation, Design Dossier Assessment, Review, Device Type, Quality Manuals, Procedures, Training Documents, etc.
  • CE Marking: CE Mark Preparation. The CE specifies the minimum safety and quality standards and the CE Mark is required for sale within the EU (European Union) and EFTA (European Free Trade Area). A Notified Body – Provides New Approach Directives assessment of conformity to CE Marking.
  • Clinical Trials: Clinical trial protocols, consulting and management
  • Medical Devices: Mandatory medical device reporting, DMF (Design Master File) submission. Medical Device Labeling and Packaging
  • International Permits: Import and Export Permits
  • Representation: Official Correspondent with FDA, Notified Body, FDA Authorized Representative and US Agent
  • IEC 60601-1-1, -2, -4 and -8 for (International Electrotechnical Commission standards for Medical Electrical Equipment – Safety, etc.)
  • IEC 61000-1 (-1, 2, 3, 4, 5 & 6) EMC (Electromagnetic Compatibility) Testing and Measurement
  • Miscellaneous: GAP Analysis reports to access current compliance prior to Pre-Audit and Registration Audit / Six sigma, lean manufacturing consulting / Process capability and process improvement studies / Preparing procedures, schedules, reports design controls product safety / SOP and ECO / Process Validation Protocols and IQ, OQ, PQ / MDR (Medical Device Reporting) / Non Conforming Materials / Test Agency Submissions / Software Validation / Risk Management / GLP Pre-Clinical Testing / GCP / Test Verification, Cleaning Validation, Biocompatibility Testing / BLA

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