US FDA

Comparison of Medical Device Standards

Whitepaper – ISO13485 & US FDA CFR 820 Comparison

Marketing medical devices at a global level can be a gruelling and onerous task when trying to achieve compliance to various differing regulations. FDA 21 CFR Part 820 compliance outlines Quality System Regulations for …

Product Quality Reviews – The Right Approach

Quality Management Systems (QMS), be it ISO or PIC/S, mandate that system reviews must occur. Product Quality Reviews (PQR) can provide the ideal platform not solely to fulfill a compliance requirement but to give …