Hi folks,
How much are you guys being charged for ISO 13485:2016 MDSAP Certification Audits?
My company is being charged about $5,250 per audit day for 7.5 days for a total about $40k a year. The scope include CE Marking, ISO 13485:2016, MDSAP Audit. And there doesn't seem to be any difference between certification and surveillance audit. Both type of audits (surveillance & re-certification) require same number of audit days and fee. Is this also your experience with your notified body?
Pete
How much are you guys being charged for ISO 13485:2016 MDSAP Certification Audits?
My company is being charged about $5,250 per audit day for 7.5 days for a total about $40k a year. The scope include CE Marking, ISO 13485:2016, MDSAP Audit. And there doesn't seem to be any difference between certification and surveillance audit. Both type of audits (surveillance & re-certification) require same number of audit days and fee. Is this also your experience with your notified body?
Pete