10 Tips for Writing Effective SOPs for Medical Device Industry
SOPs are regulatory non‑negotiables. Regulators mandate SOPs to safeguard patient safety, reduce variability, and provide auditable evidence of quality control. In most regulated markets, SOPs are mandatory for licensing, certification, and market access. SOPs form...
3D Printing Intraocular Lenses: Your Complete Guide
Intraocular lenses (IOLs) are artificial lens used to replace the natural lens that has been removed during cataract surgery. Traditionally, these lenses are produced using cast molding and lathe-cutting methods. However, these approaches restrict design flexibility....
4 Consequences of Non-Compliance with ISO 13485 Guidelines
Medical device manufacturers should comply with ISO 13485 because it ensures patient safety, enables global market access, reduces regulatory risk. Non-compliance with ISO 13485 can have serious repercussions for medical device manufacturers. This can lead to...