Replies to post #10362 on SiNtx Technologies Inc (SINT)

[boston745]

Amedica has achieved certification to the updated ISO 13485:2016 standard for its #quality management system $AMDA

Amedica Twitter Page

Management is telling us that clearance in Japan is very soon. After QMS application is reviewed PMDA approval follows!

PMDA Clearance Process - 7) Application for Investigation of QMS Conformity


Approval / Certification (Shonin / Ninsho: Japan Marketing License

Contents of QMS Applicaiton:


Japan PMDA Medical Device Regulatory Approval Process

manufacturers that perform product and quality management according to ISO 13485:2016 are considered compliant by MHLW with Chapter 2 of Ordinance No. 169

[stealthways]

Bears freaked on R/S + Bears secret DD channels = what?
looks like they know/think even clearer/better ,due to their superior inside connections, than longs that a merger is in fact in the works.....

[boston745]

I think you are confusing CNS with AAHKS2017 which is in November. CNS 2016 was late September. I doubt they ever had CNS in Nov. AAHKS in first week of Nov however.

shows.map-dynamics.com/aahks2017