All current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and ISO 9000 standards and regulations require that validation document be established and followed. Yet these regulations do not provide guidelines on how to produce …
Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy…
Debilitating neuromuscular disorders and traumatic brain, spinal cord or peripheral injuries have a devastating effect on those who suffer from them. Written from an engineering perspective, and based on a course taught by the American Society of Mechanical Engineers, Neurorehab…
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