Prioritize Process Validation To Mitigate Manufacturing Risks

By Raghu Vadlamudi, Chief Research and Technology Director, Donatelle

With patient lives, clinicians’ trust and their own businesses on the line, prudent medical device manufacturers do everything in their power to make sure their Class I, Class II and Class III products will perform as designed and intended in the field. Part of those efforts should entail process validation best practices.

Without them, manufacturers could face significant product quality risks leading to:

• Harm or even death to patients
• Delays, recalls, penalties and fines
• Damaged or, in especially adverse events, ruined industry reputation

This article outlines key considerations and components for process validation due diligence.