Product
Standard No.SS ISO 13485 : 2016
 
TitleMedical devices - Quality management systems - Requirements for regulatory purposes
 
Edition2016
 
No. of Pages51
 
ICS Classification03.100.70 Management systems
11.040.01 Medical equipment in general
 
Comments
 
SynopsisSpecifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
 
AdoptionISO 13485 : 2016 IDT
 
CommitteeBiomedical Standards Committee
 
Preview
  Download as PDF  (12 Pages, 766 KB)
 
Amendment
 
StatusCurrent
 
Available for PurchaseGlobal
 
   
   Hard Copy
   eCopy
   CD Rom
Availability:Yes, While Stocks Last
Availability:Yes
Availability:NA
Price:$49.75 (price exclude GST)
Price:$49.75 (price exclude GST)
Price:$0.00 (price exclude GST)
Quantity:Spin UpSpin Down
Quantity:Spin UpSpin Down
Quantity:Spin UpSpin Down
  Add to cart
  Add to cart
  Add to cart
* Price are subjected to Goods and Service Tax for local delivery (Singapore).