Ann: ResApp Clears Major Milestone for CE and TGA with ISO 13485, page-78

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05/06/19

08:22

Post #: 38911497
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Originally posted by Red bar: ↑

Good evening all..

According to this announcement within the thread ISO 13485 is a critical step for CE clearance and TGA certification. Since this announcement took place harmonization has also taken effect within Canada, Japan and also the United States is set align previous standards to ISO 13485. It looks like since RAP has this accreditation it holds a huge advantage in helping it obtaining FDA clearance, we are already ahead of the game!

"FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation."

https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201804&RIN=0910-AH99

"Since medical device regulators in the EU, Japan, Canada, and Australia, among others, base their quality system requirements on ISO 13485:2016, FDA can utilize this opportunity to modernize the regulation to align with a more internationally accepted quality system standard."

https://www.meddeviceonline.com/doc...roposed-rule-to-align-fda-s-qsr-with-iso-0001

Good move RAP !

Very good!!

Cheers

Red bar

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Yes exactly! The team had this box ticked and given the date of certification I’m sure that we were in compliance with the changes of the regulatory standard ISO13485:2016 being implemented in 2019. As previously mentioned, a possible delay with our CE green light is the increased workload the notified bodies have received this year due to this ISO change. My understanding is that all companies applying or current need to comply.

Keep up the great posts Red Bar!

The world awaits ResAppDx

Dave

Last edited by theworldawaits: 05/06/19

RAP Price at posting: 17.5¢ Sentiment: Buy Disclosure: Held
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