GlobalCompliancePanel has not received any gifts yet
Those who are responsible for payroll or employer tax withholding compliance or have just been hired or promoted into the payroll department would have discovered during their indoctrination just how important this role is to the success of the organization.
Their learning is a continuous process that goes on and on. Employees in this position need to build a solid foundation for handling their company's payroll obligations and complying with federal and state payroll laws. They need…Continue
Carrying out efficient and effective internal and supplier audits that meet all the requirements of external auditors is a must for medical device manufacturers. These audits should not only serve this purpose; they should also add value to the medical device organization.
Part of both ISO 13485 and QMS
Internal audits are required as part of ISO 13485 and the FDA’s Quality System Regulation (QMS). However, these procedures are quite complicated for many professionals in…Continue
A 510(K) is a premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective, meaning that which is substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA).
There are three types of Premarket Notification 510(K)’s that may be submitted to FDA: Traditional, Special, and Abbreviated. Product modifications that could significantly affect safety and effectiveness are subject to 510(K) submission…Continue
Evaluating product and processes is an imperative for almost all design and/or manufacturing companies. These are the reasons for which this evaluation needs to be made:
Lack of proper and thorough grasp of and correct implementation of statistical methods leads a company to having to…Continue