Medical device customers often say, “The design is close to lockdown.” This means that the list of requirements has been met and that the project is nearing handoff to manufacturing. The next steps ...

The authors introduce the idea of asymmetrical tolerance intervals as an aid in fully assessing product performance relative to product or process requirements. Unused, misused, or misunderstood, ...

To establish whether clinical-product quality remains constant when making a process change can be a challenging exercise. Limited data availability further complicates the assessment of whether the ...