Anna Cluet
Anna Cluet

Contamination Control: Practical Steps to Compliance with EU GMP Annex 1

By Anna Cluet
No Comments

Revised EU GMP Annex 1 requirements must be fulfilled by August 2023. Designed to protect and increase confidence in the sterility of these products, the new specifications are significant and wide-ranging, spanning the Quality system and the manufacturing process itself. Anna Cluet of Rephine discusses the practical specifics of designing and delivering a fit-for-purpose contamination control strategy.

Continue reading

Vijay Parmar
Vijay Parmar

Microbattery Advancements Will Unlock a New Wave of MedTech Innovation

By Vijay Parmar
No Comments

Microbatteries are on the cusp of a new era as solid-state lithium technology arrives to pack more energy into smaller form factors. These batteries will enable the products they power to be offered in smaller sizes and more comfortable shapes, with enormous implications for future medtech product designs and capabilities, from the convergence of hearables and OTC hearing aids to wearable devices that are used for remote health monitoring and fitness tracking.

Continue reading