04.04.23 -- ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity

The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of efficacy, minimal surface contact, reduced residue potential, and easier cleaning validation.

When subcontracting medical or optic injection-molded components, do you carefully evaluate your molder’s validation process? There is only one approach that is proven to keep your molded parts “in spec:” decoupled molding.

Examine the dynamic regulatory environment of drug-device combination products, as well as concrete steps to take to navigate regulatory complexities and decrease time-to-market.

Prototyping is essential when developing a new medical device or component. In fact, it is crucial throughout the manufacturing process in general, and key when bringing a new medical device to market. It might be even more important for medical devices, in some regards.    

When selecting an MLCC for your design, even when you know the rated capacitance for the MLCC, to ensure long-term reliability you must be aware of and consider the impacts of DC bias on your device.

To provide medical device designers with additional options, leading material manufacturers have developed low-friction additives that can be blended with medical polymers to significantly decrease surface friction and give extruded tubing a more lubricious surface. Additives can be used with most existing medical polymers without significantly affecting the original properties of the primary material.