MD&M East

Using Hypothesis Testing in Medical Packaging Validation

Figure 1. (click to enlarge) Effect of temperature on seal strength. The green bars represent samples created using low temperature. The orange indicates packages created using the high-temperature ...
BMJ

Recommendations for determining the validity of consumer wearable and smartphone step count: expert statement and checklist of the INTERLIVE network

Consumer wearable and smartphone devices provide an accessible means to objectively measure physical activity (PA) through step counts. With the increasing proliferation of this technology, consumers, ...
BMJ

Recommendations for determining the validity of consumer wearable heart rate devices: expert statement and checklist of the INTERLIVE Network

Correspondence to Dr Moritz Schumann, Institute of Cardiovascular Research and Sports Medicine, Department of Molecular and Cellular Sports Medicine, German Sport University Cologne, Koln 50858, ...
MD&M East

Process Validation Prerequisites 101

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...