InvestorsHub Logo
Followers 39
Posts 20763
Boards Moderated 1
Alias Born 07/10/2015

Re: CL101 post# 10362

Saturday, 08/19/2017 2:59:51 PM

Saturday, August 19, 2017 2:59:51 PM

Post# of 41682

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




Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent SINT News