Newsletter | May 1, 2021

05.01.21 -- April's Most Popular Articles & Solutions

Featured Editorial
Top Industry Insights
The Criticality Of Process Validation

Process validation is critical in medical device manufacturing, but it often doesn’t get the attention it requires. This article offers guidance for creating validation processes and helps identify the personnel who should create and maintain them.

Quality By Design And Design Control Roadmap For Combination Products

Quality by Design (QbD) principles help to facilitate design of products and processes that maximize the product’s efficacy and safety profile, while enhancing product manufacturability. A proposed roadmap to utilize QbD principles in conjunction with design control requirements (21 CFR 820.30 and ISO 13485) for design and manufacture of drug-device combination products based on sound science and risk management is presented.

Unique Wheelchair Opens The Road Less Traveled

The GRIT Freedom Chair features Protolabs sheet metal parts and helps persons with disabilities break through barriers.

Top Resources