Certification documents

Checklist for assessment according to ISO 13485:2016 / 93/42/Eec / 9001

Basic data organization QM in Basic data ISO 9001 + 15378

Basic data on the ISO 13485 + CMDCAS + Directive

Basic data list MD ISO 13485 + CMDCAS + Directive

Basic data MDSAP audited facility

How to complete Basic date of MDSAP audited facility

Application for product certification

Request for pre-assessment

Application for certification (First certification, extension, renewal, change notification)

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 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 for assessment according to ISO 13485 / 93/42/Eec / 9001

Checklist to assess the risk management

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