Abstract: . . .  recall or correct a device, or to notify its owners and users in Canada of its defectiveness or potential defectiveness Page 22 Therapeutic Products Directorate ISO 13485 and ISO 13488 quality system audits performed by CMDCAS recognized Registrars GD210/RevDR-MDB Element of ISO 13485:1996 QS requirement ISO 13485:1996 and ISO 9001:1994 MDR requirement P.C. 1998–783 7 May, 1998 Potential audit questions CMDCAS.13485 audit_RevDR_e.wpd 2002-12-16 Page 20 of 25 after becoming aware that the device . . .
. . .  its defectiveness or potential defectiveness Page 22 Therapeutic Products Directorate ISO 13485 and ISO 13488 quality system audits performed by CMDCAS recognized Registrars GD210/RevDR-MDB Element of ISO 13485:1996 QS requirement ISO 13485:1996 and ISO 9001:1994 MDR requirement P.C. 1998–783 7 May, 1998 Potential audit questions CMDCAS.13485 audit_RevDR_e.wpd 2002-12-16 Page 20 of 25 after becoming aware that the device : (a) may be hazardous to health; (b) may fail to conform to any claim made . . .
. . .  13485 and ISO 13488 quality system audits performed by CMDCAS recognized Registrars GD210/RevDR-MDB Element of ISO 13485:1996 QS requirement ISO 13485:1996 and ISO 9001:1994 MDR requirement P.C. 1998–783 7 May, 1998 Potential audit questions CMDCAS.13485 audit_RevDR_e.wpd 2002-12-16 Page 20 of 25 after becoming aware that the device : (a) may be hazardous to health; (b) may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics . . .
. . .  that the device : (a) may be hazardous to health; (b) may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety; or (c) may not meet the requirements of the Food and Drugs Act (R.S., c. F-27, s.1) or the MDR (SOR/DORS/98-282) Note 3 : see www.hc-sc.gc.ca/hpfb-dgpsa/inspe . . .
. . .  its defectiveness or potential defectiveness Page 22 Therapeutic Products Directorate ISO 13485 and ISO 13488 quality system audits performed by CMDCAS recognized Registrars GD210/RevDR-MDB Element of ISO 13485:1996 QS requirement ISO 13485:1996 and ISO 9001:1994 MDR requirement P.C. 1998–783 7 May, 1998 Potential audit questions CMDCAS.13485 audit_RevDR_e.wpd 2002-12-16 Page 20 of 25 after becoming aware that the device : (a) may be hazardous to health; (b) may fail to conform to any claim made . . .
. . .  complaint or reported problem related to device performance or safety? 2) recall or correct a device, or to notify its owners and users in Canada of its defectiveness or potential defectiveness Page 22 Therapeutic Products Directorate ISO 13485 and ISO 13488 quality system audits performed by CMDCAS recognized Registrars GD210/RevDR-MDB Element of ISO 13485:1996 QS requirement ISO 13485:1996 and ISO 9001:1994 MDR requirement P.C. 1998–783 7 May, 1998 Potential audit questions CMDCAS.13485 audit_RevDR_e.wpd . . .
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