HemoCue Logo
X

Select your destination

This is Hemocue's global website and may contain information on products not released in all markets.
For information on products and services in your local market, please proceed to your local Hemocue website.

Continue to Hemocue.com

MDSAP

Medical Device Single Audit Program

A single regulatory audit of a medical device manufacturer´s quality management system (QMS) to satisfy the needs of MDSAP participating regulatory authorities. Audits are performed by authorized third party auditing organizations. MDSAP Audit is based on requirements in ISO 13485 and additional regulatory requirements applicable to AU, BR, CA, JP and US.

MDSAP Certificate

Cookies are used on this site

Use of cookies