The downloadable ZIP Files contain the following formats:
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Basic data MDSAP audited facility
How to complete Basic date of MDSAP audited facility
Basic data list MD ISO 13485 + Directive
Basic data organization QM in Basic data ISO 9001 + 15378
Basic data on the ISO 13485 + Directive
Application for product certification/Notification of change
Request for pre-assessment
Application for certification (First certification, extension, renewal, change notification)
Checklist for assessment according to ISO 13485 & MDD
Checklist for reviewing the Directive 93/42/Eec
Checklist for auditing the sterilization
Checklist for auditing the sterilization by radiation
Checklist for auditing the sterilization by moist heat
Checklist for auditing the sterilization by ETO
Checklist for assessing the biological evaluation of medical devices
Checklist for the assessment of the clinical investigation of medical devices for human
Checklist for assessment of clinical evaluations acc. MEDDEV
Checklist OEM procedures
Checklist to assess the risk management