CE Marking Procedure
SKU:
SOP 7-040
$149.00
$149.00
per item
The CE Marking procedure governs the content of CE Technical Files and Design Dossier's. The CE Marking Procedure also provides instruction on device classification in accordance with Medical Device Regulation MDR (EU) 2017/745.
- MDR EU 2017/745 Compliant
- ISO 13485:2016 Compliant
- MEDDEV Compliant
- MS Word Format
- Instant Download Digital Content
CE Marking ProcedureThe CE Marking Procedure provides a method to assure that all CE Marked medical devices commercialized in the Union are in compliance with the European Medical Device Regulation MDR (EU) 2017/745.
CE Marking Procedure - OverviewThe CE Marking Procedure provides detailed instruction on the creation, content and routine maintenance of CE Technical Documentation / Design Dossier's. The CE Marking Procedure also provides instruction on device classification in accordance with the Medical Device Regulation MDR (EU) 2017/745.
CE Marking Procedure - ComplianceThe CE Marking Procedure is ISO 13485 and MDR (EU) 2017/745 compliant.
For more information about our CE Marking Procedure contact us at [email protected]
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CE Marking Procedure
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