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- Compliance with Regulations: Medical devices bearing the CE mark meet the requirements of either the Medical Devices Directive (MDD) or the Medical Devices Regulation (MDR), depending on their classification and the date of application.
- Classify Your Device: Determine the classification of your medical device according to its intended use and potential risks (Class I, IIa, IIb, III). Classification dictates the conformity assessment route and requirements.
- Classify Your Device: Determine the classification of your medical device according to its intended use and potential risks (Class I, IIa, IIb, III). Classification dictates the conformity assessment route and requirements.
- Classify Your Device: Determine the classification of your medical device according to its intended use and potential risks (Class I, IIa, IIb, III). Classification dictates the conformity assessment route and requirements.
- Device Classification: Determine the classification of your medical device according to its intended use and potential risks. Classification (Class I, IIa, IIb, III) dictates the conformity assessment route and requirements.
- Quality management systems – Requirements for regulatory purposes. Maintain and update your Quality Management System (QMS) to ensure continued compliance with ISO 13485 standards.
- 2024-08-08Requirement: Establish a robust post-market surveillance system to monitor the performance and safety of your device once it is on the market.
- Medical Device Directive (MDD) or Medical Device Regulation (MDR): Determine which regulatory framework applies to your device based on its classification and the date of application.
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