Arazy Group Blogs and Case Studies 

RDC 270/2019 Summary

Changes for Low Risk Devices in BrazilAs of May 2019, there will be a new registration notification pathway allowing medical device manufacturers to access the Brazilian market quicker. The recently published RDC 270/2019 establishes this new notification pathway...

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Calling all Consultants!

Are you a regulatory affairs consultant looking to expand your service offerings to your existing clients and increase your client base?  Arazy Group is opening Licensale for consultants in the medical and IVD device industry who wish to develop their practice....

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FDA Series- SyntheticMR

With the MRI Systems market to reach $7.9 billion by the year 2023 and the USA being the biggest market for MRI globally, it was essential that SyntheticMR received FDA clearance for their post-processing MRI software, SyMRI (versions 10 and 11). The SyMRI...

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Do You Know Your MARI%™ Score?

MARI%™ - Market Access Readiness Index Score (1-100%) Do you know exactly how ready your medical and IVD devices are to enter new markets based on their current documentation? The access to this information is available with the MARI%™ - Market Access...

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MDSAP Transition Q&A Conference Call Summary

MDSAP Transition Q&A with Health Canada (HC)  December 12, 2018 Conference Call Summary   Top 10 Highlights:   1. The deadline to transition from CMDCAS to MDSAP is January 1, 2019 for medical device license holders of Class II, III, and IV Medical...

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MDSAP Transition Q&A with Health Canada

MDSAP Transition Q&A with Health Canada (hosted by Arazy Group/ Licensale.com) Arazy Group will host Health Canada in a conference call at 10AM EST on December 12, 2018 with medical device industry participants to answer individual questions and provide...

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What is a Global Registration Map (GR-MAP™)?

What is a Global Registration Map (GR-MAP™)?   When you are dealing with multiple registrations in many countries around the world, the ability to manage them effectively and remain under control is important. At any given time, you should have access to...

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Kickstart a MedTech start-up initiative

It is not easy to bring a start-up company to success. It is even more challenging for Medtech Start-ups due to the heavily regulated nature of medical devices. For the past 22 years, we have been fortunate to witness incredible inventions and technology developed...

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