Get the free FIELD SAFETY NOTICE / PRODUCT NOTIFICATION - mhra gov
Show details
This document provides important safety information regarding the limitations in software accuracy for very small MLC field sizes within Brainlab BrainSCAN and iPlan RT treatment planning software.
We are not affiliated with any brand or entity on this form
Get, Create, Make and Sign field safety notice product
Edit your field safety notice product form online
Type text, complete fillable fields, insert images, highlight or blackout data for discretion, add comments, and more.
Add your legally-binding signature
Draw or type your signature, upload a signature image, or capture it with your digital camera.
Share your form instantly
Email, fax, or share your field safety notice product form via URL. You can also download, print, or export forms to your preferred cloud storage service.
How to edit field safety notice product online
To use the professional PDF editor, follow these steps:
1
Log in to account. Start Free Trial and register a profile if you don't have one.
2
Prepare a file. Use the Add New button. Then upload your file to the system from your device, importing it from internal mail, the cloud, or by adding its URL.
3
Edit field safety notice product. Rearrange and rotate pages, insert new and alter existing texts, add new objects, and take advantage of other helpful tools. Click Done to apply changes and return to your Dashboard. Go to the Documents tab to access merging, splitting, locking, or unlocking functions.
4
Save your file. Select it in the list of your records. Then, move the cursor to the right toolbar and choose one of the available exporting methods: save it in multiple formats, download it as a PDF, send it by email, or store it in the cloud.
It's easier to work with documents with pdfFiller than you can have ever thought. Sign up for a free account to view.
Uncompromising security for your PDF editing and eSignature needs
Your private information is safe with pdfFiller. We employ end-to-end encryption, secure cloud storage, and advanced access control to protect your documents and maintain regulatory compliance.
How to fill out field safety notice product
How to fill out FIELD SAFETY NOTICE / PRODUCT NOTIFICATION
01
Title: Clearly state 'Field Safety Notice' or 'Product Notification' at the top of the document.
02
Background: Provide a brief description of the product and the reason for the notice.
03
Risk: Detail any risks associated with the product that prompted the notice.
04
Action Required: Specify the actions that the recipient needs to take regarding the product.
05
Contact Information: Include contact details for the relevant person or department for further inquiries.
06
Distribution: Indicate how the notice will be distributed and by when.
07
Signature: Ensure it is signed by an authorized individual.
Who needs FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?
01
Healthcare professionals using the product.
02
Patients who have received the product.
03
Distributors and retailers of the product.
04
Regulatory bodies that oversee product safety.
Fill
form
: Try Risk Free
People Also Ask about
What is a field safety notice?
A 'field safety notice' (FSN) is an important communication about the safety of a medical device that is sent to customers by a device manufacturer, or their representative. FSNs tell you what you need to do to reduce the specified risks of using the medical device.
What is FSN in medical terms?
Field safety notices (FSNs): are safety communications sent out by medical device manufacturers or their representatives in relation to actions that may be taken in relation to their Medical Device that is on the market.
Is a field safety notice a recall?
Recall: it is a type of FSN where a manufacturer takes a correction or removal action to address a problem with a medical device, Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.
What is a FSCA in medical terms?
A field safety corrective action (FSCA) is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of an IVD that is already placed on the market.
What is field safety?
A field safety plan serves as a tool to document the hazard assessment, communication plan, emergency procedures, and training for staff, researchers, or students planning to engage in field activities.
What is a field safety notification?
A field safety notice (FSN) is an important means of communicating a field safety corrective action (FSCA) and related safety information to users. It may also be used to provide updated information about how an IVD should be used.
For pdfFiller’s FAQs
Below is a list of the most common customer questions. If you can’t find an answer to your question, please don’t hesitate to reach out to us.
What is FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?
A Field Safety Notice (FSN) or Product Notification is a communication issued by manufacturers to inform users about safety issues related to medical devices, including potential hazards, risks, or necessary corrective actions.
Who is required to file FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?
Manufacturers of medical devices are required to file a Field Safety Notice or Product Notification when they identify a safety concern that could affect patients or users. This may also include authorized representatives or distributors.
How to fill out FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?
To fill out a Field Safety Notice, manufacturers should include essential details such as the product name, description of the issue, affected batches, recommended actions for users, and contact information for further inquiries.
What is the purpose of FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?
The purpose of a Field Safety Notice is to ensure the safety of patients and healthcare professionals by informing them about identified risks and providing guidance on corrective actions to mitigate potential hazards.
What information must be reported on FIELD SAFETY NOTICE / PRODUCT NOTIFICATION?
The information that must be reported includes the product identification, nature of the safety issue, affected serial numbers or batches, recommended actions, measures taken, and information on how users can report problems or seek help.
Fill out your field safety notice product online with pdfFiller!
pdfFiller is an end-to-end solution for managing, creating, and editing documents and forms in the cloud. Save time and hassle by preparing your tax forms online.
Field Safety Notice Product is not the form you're looking for?Search for another form here.
Relevant keywords
Related Forms
If you believe that this page should be taken down, please follow our DMCA take down process
here
.
This form may include fields for payment information. Data entered in these fields is not covered by PCI DSS compliance.
