Drop the checkbox mentality and embrace accountability and understanding.
How much do you know about this standard? Review the results.
Part II of the ISO 13485 IQ test digs a little bit deeper into the standard.
Medical device customers can receive audits and certificates to ISO 13485:2016 to align with global regulatory requirements.
The answers are revealed, and they may surprise you.
In Part I of our ISO 13485 test, see how much you know about the basics of the standards.
How to prepare for a successful transition.
Risk Management is the single most important topic impacting the medical device industry today.
A summary of the new and revised changes in ISO 13485, the second Draft International Standard (DIS2), which is planned for release this fall.