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Archive for category: News

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TOPRA 2017, London – Global Regulatory Approaches to Improve Healthcare

Join our team at this years TOPRA Symposium!

Each year Instem attends this great event to showcase its fantastic solution Samarind RMS. Swing by our booth to discuss how we can help you with the changing global regulations and ensure you are prepared for IDMP, FDA UDI, EU MDR, and beyond.

If you would like some one-on-one time with our booth staff book a slot using the email address [email protected] or call the team on +44 1244 287 900.

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US FDA Launching New Premarket Approval (PMA) Pilot Program for High-risk Medical Devices

The FDA are currently setting up a pilot programme on several high risk medical devices, they hope that the outcome of this programme will allow them to have a more efficient PMA process.

Currently the authority is searching for nine applicants who will be enrolled from the end of September 2017 to Dec 2018, as soon as nine suitable applications are accepted the pilot will begin. It has been noted that the FDA are focusing on the quality issues of the pre-market process in order to drive down high-risk device recalls, with the ultimate goal to streamline the complex and expensive PMA process without compromising controls for safety and effectiveness of devices.

This initiative could lead to less costly and time-consuming PMA requirements for manufacturers of high-risk devices.

Here at Instem we understand that the PMA process can be long, costly and error prone. We hope that this pilot is successful and our customers can get their products to market more efficiently.

If you wanted to speak to any of our experts about Medical Device submissions or to view our solutions that will help bring your life enhancing products to market faster please reach out to us.

Speak to our team via email [email protected] or call us on +44 1244 287 900.

 

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FDA Releases Specialized CVM-only Version of eSubmitter Tool

In the news this week the Center for Veterinary Medicine have announced a veterinary specific eSubmitter tool. This new piece of tech is a step away from the FDA eSubmitter program and will be the new tool to submit to the FDA Electronic Submission Gateway.

 

The FDA describe this new submitter as a “question based submission tool” with the use of templates to enhance the user experience. The benefits focus on the specificity to the veterinary user and a better response time on bug fixes and enhancements.

It is worthy to note that you can continue to use the current FDA eSubmitter until March 2018 after this date the FDA eSubmitter will no longer support CVM submissions. Similarly as of Dec 2017 the FDA eSubmitter will not allow CVM submissions to be created within the FDA eSubmitter tool. This new CVM tech is available as of the 21st Aug 2017.

 

 

Don’t forget Samarind RMS can support your VNeeS submissions while storing and tracking your product data. If you’d like some time with our experts or to spend some time viewing a tailored RMS solution demonstration to you and your company please reach out to us. Call us on +44 1244 287 900 or write an email to [email protected]

Source: https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/

 

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Latest Release RMS v5.200

The team here at Samarind are pleased to announce our latest release of RMS 5.200!

This latest release includes key updates, bug fixes and new features, we have reached out to our current customer base providing details but if you would like to know more or are interested in a demonstration of our product please contact us via [email protected] or speak to a member of our team on +44 (0) 1244 287 900.

Check out our analytics pages, ask us about our eCTD updates and view our medical device product!

 

 

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Come and visit us at RAPS 2017!

If you are at RAPS Regulatory Convergence this September be sure to drop by our booth and meet the team!

If you would like some 1-2-1 time with our experts guarantee your slot and book in advance by writing an email to [email protected] or call +44 (0)1244 287 900. #2017RAPS

Contact us for a demo now!