New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.
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.