Intertronics has released a new white paper to demonstrate the need for robust bonding process validation in medical devices.
The paper, titled "Process Validation in Medical Device Bonding: Controlling Variables", will help medical device manufacturers minimise or eliminate process variables, ensure ISO/FDA compliance and improve reliability.
In adhesive bonding for medical device manufacture, process validation is a fundamental risk mitigation strategy.
The white paper explains how strategies in product and assembly process design can help with validation and identifies the practical challenges of creating repeatable bonding processes.
It also provides recommendations for medical device manufacturers to speed products to market, while minimising risk.
"Validation is a key safeguard for patient safety and a foundation for manufacturing efficiency, beyond just a regulatory hurdle," said Kevin Brownsill, Head of Learning and Development at Intertronics and co-author of the white paper.
"By simplifying processes and designing out variability, manufacturers can save significant time and resources while ensuring compliance."
A 2023 study by Deloitte of the FDA Medical Device Recalls Database showed that poor production and process controls accounted for 15.2% of recall reasons.
This serves as a reminder of the significant role validation plays in safeguarding compliance and patient safety.
By observing good validation practices from the design stage, med-tech companies can speed up approval timelines and minimise the risk of costly revalidation, turning new products into profit.