UDI is finally upon us, so embrace the change and begin working toward compliance.
Most of you are aware of the lack of exceptions in regards to quality and regulatory compliance. However, FDA has graciously given special dispensation to medical device establishments when it comes to three types of records – management reviews; internal audits; and supplier audits.
When implementing a Part 11 compliance program, it is all about three important words: validation; validation; and validation.
Compliance to FDA’s requirements for distribution are well-scripted and relatively easy for device manufactures to comprehend. However, it is inevitable that Mr. Murphy will eventually visit a device manufacture, resulting in Dr. D’s favorite six-letter word – RECALL.
Material management is one of the most basic functions needed to successful manufacture finished medical devices. If adequate controls are not maintained over raw materials and appropriate identification and traceability maintained, then there will probably be a FDA Form 483 observation in your organization’s future.
The underlying purpose of the Medical Device Single Audit Program is to allow one of five regulatory bodies to perform an inspection and then share the results with the other agencies so additional/duplicate inspections are not required.
What is required of an FDA compliant calibration program? How about crafting a program that actually results in inspection, measuring and test equipment actually being calibrated?
If a medical device establishment is manufacturing sterile medical devices, make sure that environmental monitoring and the calibration and servicing of environmental control systems are part of the product realization equation.
Training is one of those fundamental requirements that influences all aspects of the Quality Management System. You need to have a well-written procedure that clearly delineates the requirements for the training program. And the training needs to be documented.
One of the issues that Dr. D continues to see medical device establishments struggle with is implementing effective purchasing controls.
