Frequently Asked Questions
What is a Design History File?
You will need to maintain records known as Design History Files (DHF) documenting compliance with established design control procedures and have them ready for regulatory inspection once you obtain market authorization for your medical device. Emergo can show you how to properly create and maintain Design History Files to help ensure a more efficient QMS implementation down the line.
Do we need a QMS if we plan to outsource manufacturing?
Most likely. Even if you plan to outsource ALL manufacturing, the FDA and other agencies will hold you responsible for products you place on the market. If an incident occurs with your product, the regulatory authorities are not going to inspect your subcontractor, they will inspect your organization as the legal entity for marketing the device. Therefore, you need a QMS that demonstrates you have established procedures for controlling how your subcontractor manufacturers the product made on your behalf.
Will the FDA inspect our subcontractor?
It is most likely that a chosen subcontractor is making parts or making the entire finished devices for many medical device companies. They may already be compliant with ISO 13485 and/or FDA QSR; however, you must ensure their quality system is adequate to provide high quality components or safe and effective finished medical devices.
Even though it may be remote possibility, the FDA can still choose to inspect your subcontractor if you do not have the proper supplier controls established. In addition, the FDA requires contract manufacturers of finished medical devices to register with the FDA, so the FDA may inspect your subcontractor and you want to ensure you know that is happening.
What can happen if we have not kept systematic records of our design changes?
This can cause problems when it is time to gain regulatory approval. Often times, an organization is working quickly to introduce their product to market either to obtain initial sales or meet investor milestones. Without keeping systematic records of design controls and changes made to the product, the FDA may challenge information provided during a regulatory submission. If these records of design changes and the overall design activities are not maintained, answering those questions can be quite challenging. By implementing a pre-production QMS system, you can have a systematic method of design changes “built-in” to the process, therefore reducing difficulty in the future.