In 2018, the FDA announced the intent to “harmonize” their Quality System Regulations with ISO 13485:2016 for medical devices to streamline requirements for QSR and modernize the regulation. With the changes that have been made, you may be wondering whether there is a requirement for your medical cart manufacturer to also hold this certification. Everyone wants to stay in the FDA’s good books, and oftentimes medical carts fall into a fuzzy category. Is it a device, or is it furniture?
Today we’d like to shed a little light on some of the requirements for ISO 13485 certification in relation to medical cart manufacturers and go beyond the requirements to the advantages of this certification and how it can help you as an OEM manage risk and increase efficiencies.
Is ISO 13485 certification required for medical cart manufacturers?
The short answer is… not necessarily. In many cases, medical carts are considered office furniture and do not move from room to room. There may, however, be exceptions. It all comes down to how integrated the medical equipment is into the cart or how the cart will be used.
Section 201(h) of the Food, Drug & Cosmetic Act (FD&C Act) defines a device as:
"An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals"
Should your medical cart manufacturer be ISO 13485 certified?
It may not be required, but it is definitely recommended. At HUI, we committed to the ISO 13485 certification for the peace of mind of our customers and the fact that it took HUIs quality system to the next level. When everyone understands the same requirements for quality, risk management, and traceability, it is a huge advantage to the development and launch of your device cart.
What are the advantages of working with an ISO 13485-certified cart manufacturer for your medical device?
Working with a medical cart manufacturer who already understands and is creating the required documentation will make it much easier for your team to gather the correct information in a format that “translates” into the correct compliance requirements. If you work with a cart manufacturer that is not ISO 13485 certified, chances are that you will have to expend a lot of resources to train and close the gaps with their documentation and assist in getting their QMS up to par.
The ISO 13485 certification process requires manufacturers to understand, internalize, and use risk management procedures in the development and production of products. At HUI, this aspect of certification influenced our organizational processes and required us to think differently. When we take on a medical cart project, we begin assessing, error proofing, and ultimately mitigating risk from the get-go, helping us identify problems before they start. HUI’s Director of Quality & Regulatory Affairs Tim Jandrey states, “The risk management process is so valuable to HUI and the customer. Honestly, you really can’t expect to successfully launch a new product in this industry without good risk management procedures in place.”
In the unfortunate event of a recall or other serious quality issue, having an ISO 13485 medical cart manufacturer as a supplier gives you the assurance that traceability systems are in place and can be used to correctly identify the source of any problems. In the case of HUI, our transition to ISO 9001 and ISO 13485 certification provided an opportunity for us to include traceability right in our shop floor management software. If a piece of hardware were to malfunction on a cart out in the field, traceability enables HUI to efficiently and accurately identify any and all of the other carts ran containing that same lot of hardware. We are also able to identify any and all current inventory on hand that might have the same issue and instantly quarantine that raw material. Without this ability, our customer base could potentially be taking on a lot more risk, because it would be nearly impossible to accurately identify the carts that potentially have the same issue.
If you’re interested in learning more about our ISO certificates, or if you’d like to work with an ISO-certified contract manufacturer, please contact us today!