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Regulatory Compliance in Global Medical Device Industry

Explore stringent regulations in the global medical device industry, covering US (FDA), European Community (CE mark), EFTA standards, and international directives. Learn about safety, risk assessment, and requirements for various device types. Discover the role of Notified Bodies and ISO 9000 standards for device documentation. Dive into the job responsibilities of certifying bodies and key players in worldwide medical device regulations.

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Regulatory Compliance in Global Medical Device Industry

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  1. Chapter 18 Regulations Tracking

  2. Regulations • US: FDA, almost all devices, almost all drugs • European Community: devices so far, CE mark is the goal. • Active implantable medical devices (1993) • In-vitro Diagnostic Medical Devices Directive (1997) • EFTA 380 million

  3. US Standards • Regulatory – law based • National voluntary consensus • IEEE, ASME, ANSI, ISO, … • Foreign national • International

  4. Medical Device Directives • “any instrument, appliance, apparatus, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

  5. Diagnosis, prevention, monitoring, treatment or alleviation of disease • Diagnosis, monitoring alleviation or compensation for injury or handicap • Investigation, replacement or modification of the anatomy or of a physiological process • Control of conception; • And which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means”

  6. Medical Device Directives: • Active Implantable Medical Device – depends on power source other than human body, which is partially or totally inserted, which remains after the procedure, … • Medical Device Directive (all not above or below) • In Vitro Medical Device – reagents, calibrator, instrument, dx valoue

  7. General requirements for devices • Safe, low risk • Perform re specs • Safe throughout lifetime of device • Safe in environments, transport, etc • High benefits/risk

  8. Specific requirements for devices • Chemical, physical, bio pptys • Infection, sterilization • Construction, environmental propoerties • Measurement reliability • Hazard mitigation • …checklists…

  9. Notified Body • Independent judge of device… • Competent judge of device… • Trained, experienced staff • Integrity • Impartial • … Lloyds of London

  10. Job description • Audit, examine, survey, verify,attest, certify, communicate results, act as gatekeeper if errors found, … • Certify declaration of conformity, which allows CE mark…

  11. ISO 9000 • General listing of overall requirement that must be met for documentation of devices. • Specific levels for device type. Data required includes design control, QSR, servicing, etc…

  12. Other major players • Canada – somewhat between US & EU • Pacific Rim – tending toward EU

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