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Boston Scientific International S.A.
EMEA Headquarters
Side social : PARC du Val Saint Quentin 2 rue Men Cauldron
78960 Visits LE Cretonne France
Tel 33 (0)1 39 30 97 00
Fax 33 (0)1 39 30 97 99
www.bostonscientific.comReference:
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How to fill out urgent field safety notice
How to fill out urgent field safety notice
01
Obtain the necessary template for the urgent field safety notice.
02
Fill out the contact information, including the name of the company and the person responsible.
03
Provide a detailed description of the safety issue or defect that requires urgent attention.
04
Include any relevant information or instructions for stakeholders or customers.
05
Clearly state the urgency of the issue and any recommended actions to be taken.
06
Review the completed urgent field safety notice for accuracy and clarity before sending it out.
Who needs urgent field safety notice?
01
Any organization or individual involved in the manufacturing, distribution, or use of a product that has a safety issue or defect that poses a risk to consumers or the public may need an urgent field safety notice. This includes manufacturers, distributors, retailers, and regulatory authorities.
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What is urgent field safety notice?
An urgent field safety notice is a communication issued by a manufacturer to inform users and stakeholders about a safety issue with a medical device that may pose risks to health and requires immediate attention.
Who is required to file urgent field safety notice?
Manufacturers of medical devices are required to file an urgent field safety notice to notify regulatory authorities, users, and healthcare professionals about potential safety concerns.
How to fill out urgent field safety notice?
To fill out an urgent field safety notice, provide detailed information about the safety issue, the affected product, actions to be taken by users, and any reporting requirements. It should be clear, concise, and include contact information for follow-up.
What is the purpose of urgent field safety notice?
The purpose of an urgent field safety notice is to alert users to a potential safety hazard associated with a medical device and provide guidance on corrective actions to minimize risk to patients and users.
What information must be reported on urgent field safety notice?
The notice must report information such as product details, nature of the safety issue, affected batch numbers, recommendations for action, and the timeframe for reporting back on compliance.
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