Incident Management and Human Error Prevention Workshops
NSF International has announced up-coming workshops in September, including topics such as incident management and human error prevention.
Ginolis to Showcase Automated Optical Inspection System at the AACC Clinical Lab Expo
Ginolis has announced it will be introducing the Ginolis Pixie at the AACC Clinical Lab Expo in Chicago, US.
Summarising the IVDR Challenge
The new in-vitro diagnostic regulation (IVDR) entered into force on 26 May 2017. As the date of application for the IVDR is 26 May 2022, 20% of the transitional period of five years has already passed. This is a good opportunity to summarise the current situation.
Happy Birthday MDR
The Medical Device Regulation (MDR) entered into force on May 26th 2017. Since then, it has been the focus of almost all relevant medical device conferences and training institutions, including LinkedIn groups, webinars and internet blogs.
A Comprehensive Overview of Design Verification
The US Food and Drug Administration (FDA) and the international regulatory standards continue to evolve and become more stringent. Medical devices are also becoming smaller and more complex in design and their functionality. This makes the process of design verification even more important, not only to comply with regulations but also to design the highest-quality part and production process.