When a manufacturer first decides to enter the medical device marketplace, for many types of product and markets, a key element in gaining regulatory approval is the quality system. Even if an ISO 9001-compliant QMS is already in place, a number of critical additional requirements apply to device manufacture.
Gap Analysis is a process in which the current state of the quality system is audited and compared with the requirements of the desired or ‘future state’ quality system. The resulting ‘gaps’ in compliance to the ‘future state’ condition provide the basis of the Corrective and Preventive Action Plan to achieve the ‘future state’ quality system.
From time to time, it is also important to determine if your quality system has become the victim of ‘scope-creep'. This is especially important if your quality system has been operating for a significant period of time or if you are introducing new regulatory requirements or product families.
GEMAR will ensure that your quality system needs are completely identified and will partner you to ensure achievement of your future-state quality system needs.
Please contact us to see how we can help.