Insight Technology aims to provide guidance for a risk-based approach to NPD, QA/RA compliance, remediation, process validation, change control, CAPA, and supplier management to medical device manufacturers, or pharmaceutical companies with combination products.

Mark Shal, founded the company in January 2008. He offers sixteen (16) years of hands-on experience establishing, leading and improving QA/RA and NPD activities of drug delivery devices in endovascular, orthopedics, and infusion markets. He has participated, and  guided quality, and R/D activities from vendor/component qualification to design control, process measurement, and test method validation to PMA/510 (k)/ISO clearance and post-market surveillance. Devices included hardware, software, and disposable pumps, stents, and catheters.
His education, training, consulting, and counseling experiences facilitate transfer of knowledge to speed up quality improvement, new product development, and regulatory compliance.

His full resume may be downloaded from the Insights page.