The Ministry of Food and Drug Safety (MFDS, formerly known as the Korea Food & Drug Administration or KFDA) is the governmental agency that regulates...
QMS Compliance for Startup Medical Device Companies
Implementing and maintaining a quality management system (QMS) is a crucial part of regulatory compliance for most markets worldwide.
For small medical device manufacturers in the pre-production phase, an initial implementation of a partial quality system is an extremely beneficial way to ensure compliance with product development regulations, such as Design Controls.
Pre-production QMS for eventual compliance with FDA QSR and ISO 13485
While a quality system typically does not have to be fully implemented until you begin your medical device registration, implementing an initial partial QMS system can make implementing a full QMS less burdensome, and may shorten your time to commercialization in the long run.
A pre-production QMS is ideal for medical device manufacturers that are 18-24 months away from commercialization and distribution. The benefit for this approach is to allow the organization to build and improve their quality system as they proceed through design and development, validation testing, conducting clinical trials, and eventually market launch.
Compliance with design control procedures
The US Food and Drug Administration (FDA) and other market regulators require proof of compliance with established design control procedures for some device classifications. It is important to show ongoing compliance all the way from device conception through release to market.
To ensure ongoing compliance with quality system procedures, you should evaluate your pre-production QMS using internal audits at least once a year. Conducting periodic internal audits also supports the evolution of the QMS when new processes are added to the system as the organization approaches launch of the product.
We can help you implement a pre-production QMS
Emergo has extensive expertise helping companies worldwide establish quality systems compliant with ISO 13485, FDA Quality System Regulation and other global QMS requirements. Our experienced consultants can establish procedures for regulatory compliance tailored to the specific markets you’re interested in entering.
As part of your QMS implementation, we will set up procedures for the following:
- Document and records control
- Training on regulatory requirements and internal procedures
- Design and development
- Risk management
- Software development (if applicable)
- Supplier evaluation
- Control of measurement equipment
We can also perform internal quality system audits if you do not have the staff or resources to do so.
Please contact us for more information about our pre-production QMS service.
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.
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