When we say we have thought leaders at RQM+, we mean it. 👑

Small in duration but big in substance, this four-minute MedTech Voices clip features Senior VP of Intelligence and Innovation Amie Smirthwaite, PhD, FRAPS sharing her ISO 18969 journey.
 
We don't want to say too much because we'll spoil the clip!
 
What we will say is that Amie's initiative is leading to the development of the first ISO standard for clinical evaluation of medical devices. Work is ongoing; while the standard will be harmonized, it's intended to be applicable to any regulatory geography, and emphasizes a scientific approach rather than addressing specific regulations.