Regulatory Insight, Inc. has a complete electronic library of quality system procedures written to comply with the most current worldwide regulations and standards, including US FDA’s Quality System Regulation and ISO-13485:2003. We can customize a Quality Manual and a set of Quality System Procedures specific to your company’s operations. This can be accomplished remotely and sent to you electronically without necessarily the need for on-site visits.
If your company already has a Quality Manual and a set of Quality System Procedures but you are not sure whether they are in full compliance, Regulatory Insight can perform a gap analysis to determine if and where your procedures may fall short of regulatory body requirements. This may be done on-site or remotely; whichever you prefer.
Please contact us to learn more about how Regulatory Insight, Inc. may audit and augment your company’s current quality system to ensure full compliance with current worldwide regulations and standards or assist in the design and development of a new quality system.
