Expert Advice Community

Guest

Applicability of ISO 13485 for medical device store

  Quote
Guest
Guest user Created:   Apr 01, 2019 Last commented:   Apr 01, 2019

Applicability of ISO 13485 for medical device store

Could you please give me a brief summary about ISO 13485 including its importance/applicability for a medical device store (not manufacture)?
0 0

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Verlene Law Apr 01, 2019

Answer:

In the context of a medical device store, Good Distribution Practice (country specific regulation) would be more applicable in your case . ISO 13485 is an international standard and guideline to provide medical device companies a framework to establish their Quality Management System (QMS). For the context of a medical device store, your role would be more involved in ensuring that product that does not conform to requirements are identified, segregated, stored appropriately to prevent their unintended use or delivery.
Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Apr 01, 2019

Apr 01, 2019

Suggested Topics

Guest Created:   Jan 12, 2023 ISO 13485 & EU MDR
Replies: 1
0 0

Preventive action

Guest Created:   Jan 11, 2023 ISO 13485 & EU MDR
Replies: 1
0 1

Purchase (vendors) scorecards