Regulatory Open Forum

Cost of Stage 1 (Offsite review of CA and US QMS documentation) +
Cost of Stage 2 (Onsite audit to CA and US QMS requirements) +
Annual registration fee >/=
Cost of CMDCAS x 3

To me, the idea that people switching to MDSAP from CMDCAS should be prepared to pay at least 3 times what they were spending for the CMDCAS holds true ONLY if you assume one of two things:

1) They market in some jurisdiction in addition to Canada, and therefore are paying for the cost of onsite audits for at least two MDSAP jurisdictions. If they market only in Canada, and are audited only to CA requirements, based on the above, the cost is likely to be less than 3 times what they were spending for the CMDCAS.

2) The only two MDSAP jurisdictions in which they market medical devices are Canada and the US, and the off-site review of US QMS documentation and the onsite audit to US requirements

Cost of Stage 1 (Offsite review of CA and US QMS documentation) +
Cost of Stage 2 (Onsite audit to CA and US QMS requirements) +
Annual registration fee >/=
Cost of CMDCAS x 3

To me, the idea that people switching to MDSAP from CMDCAS should be prepared to pay at least 3 times what they were spending for the CMDCAS holds true ONLY if you assume one of two things:

1) They market in some jurisdiction in addition to Canada, and therefore are paying for the cost of onsite audits for at least two MDSAP jurisdictions. If they market only in Canada, and are audited only to CA requirements, based on the above, the cost is likely to be less than 3 times what they were spending for the CMDCAS.

2) The only two MDSAP jurisdictions in which they market medical devices are Canada and the US, and the off-site review of US QMS documentation and the onsite audit to US requirements

• the manufacturer must have been fairly small -- ISO 13485 under CMDCAS audit duration depends on the number of employees (which as a former CB Technical Manager never really made much sense to me since it generally takes as long to audit a QMS whether the company has many or few employees) whereas MDSAP audit duration is based on the number of processes
• they are making a comparison to an established QMS audit plan -- MDSAP is going to start at the beginning (hence having a Stage 1 audit) whereas they were probably having only Stage 2 and Surveillance audits
• more is covered in an MDSAP audit vs. ISO 13485 under CMDCAS -- MDSAP is going to cover ISO 13485, US FDA 21 CFR 820 and Canada's CMDR; their ISO 13485 under CMDCAS audits won't be as comprehensive and cover US FDA.

Cost of Stage 1 (Offsite review of CA and US QMS documentation) +
Cost of Stage 2 (Onsite audit to CA and US QMS requirements) +
Annual registration fee >/=
Cost of CMDCAS x 3

To me, the idea that people switching to MDSAP from CMDCAS should be prepared to pay at least 3 times what they were spending for the CMDCAS holds true ONLY if you assume one of two things:

1) They market in some jurisdiction in addition to Canada, and therefore are paying for the cost of onsite audits for at least two MDSAP jurisdictions. If they market only in Canada, and are audited only to CA requirements, based on the above, the cost is likely to be less than 3 times what they were spending for the CMDCAS.

2) The only two MDSAP jurisdictions in which they market medical devices are Canada and the US, and the off-site review of US QMS documentation and the onsite audit to US requirements

• the manufacturer must have been fairly small -- ISO 13485 under CMDCAS audit duration depends on the number of employees (which as a former CB Technical Manager never really made much sense to me since it generally takes as long to audit a QMS whether the company has many or few employees) whereas MDSAP audit duration is based on the number of processes
• they are making a comparison to an established QMS audit plan -- MDSAP is going to start at the beginning (hence having a Stage 1 audit) whereas they were probably having only Stage 2 and Surveillance audits
• more is covered in an MDSAP audit vs. ISO 13485 under CMDCAS -- MDSAP is going to cover ISO 13485, US FDA 21 CFR 820 and Canada's CMDR; their ISO 13485 under CMDCAS audits won't be as comprehensive and cover US FDA.

Cost of Stage 1 (Offsite review of CA and US QMS documentation) +
Cost of Stage 2 (Onsite audit to CA and US QMS requirements) +
Annual registration fee >/=
Cost of CMDCAS x 3

To me, the idea that people switching to MDSAP from CMDCAS should be prepared to pay at least 3 times what they were spending for the CMDCAS holds true ONLY if you assume one of two things:

1) They market in some jurisdiction in addition to Canada, and therefore are paying for the cost of onsite audits for at least two MDSAP jurisdictions. If they market only in Canada, and are audited only to CA requirements, based on the above, the cost is likely to be less than 3 times what they were spending for the CMDCAS.

2) The only two MDSAP jurisdictions in which they market medical devices are Canada and the US, and the off-site review of US QMS documentation and the onsite audit to US requirements

• the manufacturer must have been fairly small -- ISO 13485 under CMDCAS audit duration depends on the number of employees (which as a former CB Technical Manager never really made much sense to me since it generally takes as long to audit a QMS whether the company has many or few employees) whereas MDSAP audit duration is based on the number of processes
• they are making a comparison to an established QMS audit plan -- MDSAP is going to start at the beginning (hence having a Stage 1 audit) whereas they were probably having only Stage 2 and Surveillance audits
• more is covered in an MDSAP audit vs. ISO 13485 under CMDCAS -- MDSAP is going to cover ISO 13485, US FDA 21 CFR 820 and Canada's CMDR; their ISO 13485 under CMDCAS audits won't be as comprehensive and cover US FDA.

Cost of Stage 1 (Offsite review of CA and US QMS documentation) +
Cost of Stage 2 (Onsite audit to CA and US QMS requirements) +
Annual registration fee >/=
Cost of CMDCAS x 3

To me, the idea that people switching to MDSAP from CMDCAS should be prepared to pay at least 3 times what they were spending for the CMDCAS holds true ONLY if you assume one of two things:

1) They market in some jurisdiction in addition to Canada, and therefore are paying for the cost of onsite audits for at least two MDSAP jurisdictions. If they market only in Canada, and are audited only to CA requirements, based on the above, the cost is likely to be less than 3 times what they were spending for the CMDCAS.

2) The only two MDSAP jurisdictions in which they market medical devices are Canada and the US, and the off-site review of US QMS documentation and the onsite audit to US requirements

• the manufacturer must have been fairly small -- ISO 13485 under CMDCAS audit duration depends on the number of employees (which as a former CB Technical Manager never really made much sense to me since it generally takes as long to audit a QMS whether the company has many or few employees) whereas MDSAP audit duration is based on the number of processes
• they are making a comparison to an established QMS audit plan -- MDSAP is going to start at the beginning (hence having a Stage 1 audit) whereas they were probably having only Stage 2 and Surveillance audits
• more is covered in an MDSAP audit vs. ISO 13485 under CMDCAS -- MDSAP is going to cover ISO 13485, US FDA 21 CFR 820 and Canada's CMDR; their ISO 13485 under CMDCAS audits won't be as comprehensive and cover US FDA.

Cost of Stage 1 (Offsite review of CA and US QMS documentation) +
Cost of Stage 2 (Onsite audit to CA and US QMS requirements) +
Annual registration fee >/=
Cost of CMDCAS x 3

To me, the idea that people switching to MDSAP from CMDCAS should be prepared to pay at least 3 times what they were spending for the CMDCAS holds true ONLY if you assume one of two things:

1) They market in some jurisdiction in addition to Canada, and therefore are paying for the cost of onsite audits for at least two MDSAP jurisdictions. If they market only in Canada, and are audited only to CA requirements, based on the above, the cost is likely to be less than 3 times what they were spending for the CMDCAS.

2) The only two MDSAP jurisdictions in which they market medical devices are Canada and the US, and the off-site review of US QMS documentation and the onsite audit to US requirements

• the manufacturer must have been fairly small -- ISO 13485 under CMDCAS audit duration depends on the number of employees (which as a former CB Technical Manager never really made much sense to me since it generally takes as long to audit a QMS whether the company has many or few employees) whereas MDSAP audit duration is based on the number of processes
• they are making a comparison to an established QMS audit plan -- MDSAP is going to start at the beginning (hence having a Stage 1 audit) whereas they were probably having only Stage 2 and Surveillance audits
• more is covered in an MDSAP audit vs. ISO 13485 under CMDCAS -- MDSAP is going to cover ISO 13485, US FDA 21 CFR 820 and Canada's CMDR; their ISO 13485 under CMDCAS audits won't be as comprehensive and cover US FDA.

Cost of Stage 1 (Offsite review of CA and US QMS documentation) +
Cost of Stage 2 (Onsite audit to CA and US QMS requirements) +
Annual registration fee >/=
Cost of CMDCAS x 3

To me, the idea that people switching to MDSAP from CMDCAS should be prepared to pay at least 3 times what they were spending for the CMDCAS holds true ONLY if you assume one of two things:

1) They market in some jurisdiction in addition to Canada, and therefore are paying for the cost of onsite audits for at least two MDSAP jurisdictions. If they market only in Canada, and are audited only to CA requirements, based on the above, the cost is likely to be less than 3 times what they were spending for the CMDCAS.

2) The only two MDSAP jurisdictions in which they market medical devices are Canada and the US, and the off-site review of US QMS documentation and the onsite audit to US requirements

• the manufacturer must have been fairly small -- ISO 13485 under CMDCAS audit duration depends on the number of employees (which as a former CB Technical Manager never really made much sense to me since it generally takes as long to audit a QMS whether the company has many or few employees) whereas MDSAP audit duration is based on the number of processes
• they are making a comparison to an established QMS audit plan -- MDSAP is going to start at the beginning (hence having a Stage 1 audit) whereas they were probably having only Stage 2 and Surveillance audits
• more is covered in an MDSAP audit vs. ISO 13485 under CMDCAS -- MDSAP is going to cover ISO 13485, US FDA 21 CFR 820 and Canada's CMDR; their ISO 13485 under CMDCAS audits won't be as comprehensive and cover US FDA.

Cost of Stage 1 (Offsite review of CA and US QMS documentation) +
Cost of Stage 2 (Onsite audit to CA and US QMS requirements) +
Annual registration fee >/=
Cost of CMDCAS x 3

To me, the idea that people switching to MDSAP from CMDCAS should be prepared to pay at least 3 times what they were spending for the CMDCAS holds true ONLY if you assume one of two things:

1) They market in some jurisdiction in addition to Canada, and therefore are paying for the cost of onsite audits for at least two MDSAP jurisdictions. If they market only in Canada, and are audited only to CA requirements, based on the above, the cost is likely to be less than 3 times what they were spending for the CMDCAS.

2) The only two MDSAP jurisdictions in which they market medical devices are Canada and the US, and the off-site review of US QMS documentation and the onsite audit to US requirements

Cost of Stage 1 (Offsite review of CA and US QMS documentation) +
Cost of Stage 2 (Onsite audit to CA and US QMS requirements) +
Annual registration fee >/=
Cost of CMDCAS x 3

To me, the idea that people switching to MDSAP from CMDCAS should be prepared to pay at least 3 times what they were spending for the CMDCAS holds true ONLY if you assume one of two things:

1) They market in some jurisdiction in addition to Canada, and therefore are paying for the cost of onsite audits for at least two MDSAP jurisdictions. If they market only in Canada, and are audited only to CA requirements, based on the above, the cost is likely to be less than 3 times what they were spending for the CMDCAS.

2) The only two MDSAP jurisdictions in which they market medical devices are Canada and the US, and the off-site review of US QMS documentation and the onsite audit to US requirements

Cost of Stage 1 (Offsite review of CA and US QMS documentation) +
Cost of Stage 2 (Onsite audit to CA and US QMS requirements) +
Annual registration fee >/=
Cost of CMDCAS x 3

To me, the idea that people switching to MDSAP from CMDCAS should be prepared to pay at least 3 times what they were spending for the CMDCAS holds true ONLY if you assume one of two things:

1) They market in some jurisdiction in addition to Canada, and therefore are paying for the cost of onsite audits for at least two MDSAP jurisdictions. If they market only in Canada, and are audited only to CA requirements, based on the above, the cost is likely to be less than 3 times what they were spending for the CMDCAS.

2) The only two MDSAP jurisdictions in which they market medical devices are Canada and the US, and the off-site review of US QMS documentation and the onsite audit to US requirements

Cost of Stage 1 (Offsite review of CA and US QMS documentation) +
Cost of Stage 2 (Onsite audit to CA and US QMS requirements) +
Annual registration fee >/=
Cost of CMDCAS x 3

To me, the idea that people switching to MDSAP from CMDCAS should be prepared to pay at least 3 times what they were spending for the CMDCAS holds true ONLY if you assume one of two things:

1) They market in some jurisdiction in addition to Canada, and therefore are paying for the cost of onsite audits for at least two MDSAP jurisdictions. If they market only in Canada, and are audited only to CA requirements, based on the above, the cost is likely to be less than 3 times what they were spending for the CMDCAS.

2) The only two MDSAP jurisdictions in which they market medical devices are Canada and the US, and the off-site review of US QMS documentation and the onsite audit to US requirements

Cost of Stage 1 (Offsite review of CA and US QMS documentation) +
Cost of Stage 2 (Onsite audit to CA and US QMS requirements) +
Annual registration fee >/=
Cost of CMDCAS x 3

To me, the idea that people switching to MDSAP from CMDCAS should be prepared to pay at least 3 times what they were spending for the CMDCAS holds true ONLY if you assume one of two things:

1) They market in some jurisdiction in addition to Canada, and therefore are paying for the cost of onsite audits for at least two MDSAP jurisdictions. If they market only in Canada, and are audited only to CA requirements, based on the above, the cost is likely to be less than 3 times what they were spending for the CMDCAS.

2) The only two MDSAP jurisdictions in which they market medical devices are Canada and the US, and the off-site review of US QMS documentation and the onsite audit to US requirements