by Administrator BMCT | Jul 16, 2025 | Bez kategorii
Under EU MDR Article 117, manufacturers of medicinal products with integral device components (like pre-filled pens, syringes, inhalers) must submit a Notified Body Opinion (NBOp) as part of their Marketing Authorisation Application (MAA) — unless the device part...
by Administrator BMCT | Jan 22, 2025 | Bez kategorii
In the fast-evolving world of medical devices, pen injectors play a pivotal role in ensuring accurate and efficient drug delivery. Drawing from the latest standards such as ISO 11608 series, here are the key elements critical to successful pen development:1. System...
