For a quality manager in the medtech sector, choosing a 3D printing supplier isn't simply a technical assessment, but a decision linked to risk management. Every component produced can enter the medical device's technical file. Every non-conformity can generate a CAPA. Every MDR or FDA audit, sooner or later, can extend to the supply chain as well. The operational question, therefore, isn't: "Can…
Quality professionals in the life sciences industry are dedicated to achieving the highest standards of quality, safety, and efficacy in all products, while also improving manufacturability.
Medicines must meet the intended use. To accomplish this, they employ an effective and systematic approach known as Quality By Design (QbD) methodology that facilitates:
- Product development
- Process unders…
