Are Your Training Effectiveness Methods Really Effective?
ISO 13485:2016 section 6.2c requires that with regards to training, an organization evaluates the effectiveness of the actions taken. The methodology used to Continue Reading
Audit Trails and Tales
Welcome!
I haven’t boarded a flight or had a hotel reservation since February 2020. This is the longest stretch—by far–that I’ve been home in Continue Reading
EU MDR 2017/745
- Replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC)
- The regulation went into effect May 26, 2021 (Date of Application). This date was delayed due to
ISO 13485:2016
- ISO 13485 is a voluntary quality system standard
- Generic in nature
- Management is held accountable for the quality management system
- Appropriate for medical device manufacturers, contract manufacturers, component manufacturers, service
21 CFR Part 820
- This is a quality system regulation, not a voluntary standard
- The QSR is generic in nature due to the fact that there are more than 12k devices in the marketplace
ISO 9001:2015
- This is a voluntary quality system standard, each organization has the flexibility to implement their quality system in a manner that is most appropriate to them
- Not industry-specific
- Management is