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Video: Notified body perspective on CE-marked medical devices versus article 117 MDR combination products

With the implementation of the MDR, the Marketing authorization holder (MAH) must also show compliance for the device part of...

Video: The design and qualification process for a LVP packaging system from a user perspective; case study nitrosamines

To meet the increasing patient need for LVP, more complex packaging systems are required to be designed and further qualified...

Bioburden Alert and Action Levels – Low hanging fruit for a FDA Citation

Most standards regarding bioburden and environmental testing refer to establishing alert and action levels. These standards sometimes include guidance, however,...

Video: Blow-fill-seal technology in large volume parenteral packaging

Blow-fill-seal is the advanced aseptic technology for the efficient production of containers (e.g. bags or bottles) for large volume parenterals...

Design Change Impact on Biocompatibility and Documentation

Change Management, especially related to a medical device’s design, is one of the most commonly-cited issues in FDA 483s and...