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Important note: A separate form must be completed for each MD SAP audited site. Please follow the instruction of guidance document \”How to complete Basic Data of MD SAP audited facility\”.DNS
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How to fill out changes to medical device

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How to fill out changes to medical device

01
Read the instructions provided by the manufacturer carefully.
02
Identify the specific changes that need to be made to the medical device.
03
Use appropriate tools or equipment, if required, to make the changes.
04
Ensure that you have the necessary knowledge or expertise to make the changes safely.
05
Follow any additional guidelines or regulations related to the changes.
06
Document the changes made to the medical device.
07
Test the device after making the changes to ensure its functionality and safety.
08
If the changes involve software modifications, follow the relevant software development lifecycle processes.
09
Seek assistance from a professional or contact the manufacturer if you encounter difficulties or uncertainties during the process.

Who needs changes to medical device?

01
Medical device manufacturers
02
Healthcare providers or institutions
03
Biomedical engineers or technicians
04
Research and development teams
05
Regulatory bodies or authorities
06
Individuals with specific medical conditions that require customized modifications to a device

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Changes to medical devices refer to modifications in design, manufacturing processes, labeling, or intended use that may affect the safety or effectiveness of the device.
Manufacturers of medical devices are required to file changes to the medical device with the appropriate regulatory authorities.
To fill out changes to a medical device, manufacturers must complete the necessary forms provided by regulatory authorities, detailing the changes made and providing supporting documentation as needed.
The purpose of changes to medical devices is to ensure ongoing compliance with safety and efficacy standards, allowing regulators to monitor and maintain the quality of medical devices in the market.
The information that must be reported includes the nature of the change, rationale behind it, any potential impacts on device safety or effectiveness, and updated labeling if applicable.
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