WHAT YOU CAN’T SEE CAN HURT YOU.
DON'T PUT YOUR PATIENTS AT RISK.
ARE YOUR VENDORS
UP TO DATE?
The medical device industry has shifted to a higher standard,
introducing a growing divide in quality and patient safety assurance.
A generic framework to enhance customer satisfaction in a wide range of industries; not focused on the safety and efficacy of medical devices.
A rigorous, patient-focused and risk-based quality management system to ensure those in the high-risk medical device industry are delivering the highest level of patient safety and quality.
THERE IS NO SUCH THING AS A HARMLESS SHORTCUT
Third-party ISO 13485:2016 certification ensures patient safety
isn't compromised at any step of the medical device lifecycle.
3 KEY REQUIREMENTS
(OUT OF 80+) TO ILLUSTRATE WHY ISO 13485:2016
IS THE ONLY ACCEPTABLE STANDARD.
YOUR DOCTORS AND NURSES WON'T FAIL HER.
MAKESURE YOUR EQUIPMENT DOESN'T EITHER.
|ISO 9001||ISO 13485|
|Determine, monitor and review external and internal issues|
|Use risk-based thinking for planning and management|
|Provide and maintain resource monitoring|
|Monitor and analyze implementation with an internal audit program|
|Utilize risk-based approaches that consider patient safety through every step|
|Provide early warning of quality issues through a feedback system|
|Investigate equipment incidents reported through customer feedback|
|Maintain the suitability and effectiveness of the quality management system|
|Control medical devices with regard to advisory notices (product recalls, etc.)|
|Control the work environment to prevent contamination|
|Retain obsolete controlled documents for the life of the medical device|
|Staff trained and supervised to work in special conditions (bloodborne pathogens, etc.)|
|Control of customer property, including confidential health information|
|Validation of computer software|
|Full traceability of devices, including documents and records|