When Is Quality Management System (QMS) Required for the Medical Devices Industry?

Establishing an efficient and effective quality management system (QMS) has been a recurring quest for most medical device companies. Whether sticking with that good old paper-based system that has been in place for a while, that might not be the best but something they are familiar with, or implementing a general-purpose QMS software tool that might eventually lead to improved efficiencies but only after spending months and many valuable resources to configure and customize the tool to attempt to make it work.
A medical device quality management system (QMS) is a structured system of procedures and processes covering all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and more.
Most medical devices will require some form of a QMS; the complexity of the QMS will vary based on the classification of the device.

When Is QMS required for medical devices?

It is always hard to decide when you should implement a quality management system for your medical device company, especially since any company needs between 3 to 9 months to fully institute a QMS. Therefore, you should look at the market you are targeting.
In the US, compliance with FDA 21 CFR Part 820 regulations is required when your medical device is registered for marketing. Also, if your company produces medium to high-risk medical devices, you will have to go through the 510(K) processes.
During the process of submitting the 510(K), you are expected to comply with 21 CFR Part 820. When you register your Class I or Class II medical devices, the FDA will enforce compliance through random inspections.
Whereas, in most European counties, your company will have to obtain the CE Marking for your medical device before you can distribute it. Except when the medical device is a Class I non-sterile, non-measuring, and non-reusable surgical instrument, you will only be able to get the CE Marking if you meet the requirements of Article 10 and Annex IX of the new EU Medical Device Regulations (EU MDR). For most companies, these requirements are met through certification to ISO 13485:2016.

Benefits of QMS for the medical devices industry

• Demonstrate compliance with regulatory and legal requirements
• Ensure the establishment of QMS practices that consistently yield safe and effective medical devices
• Manage risk effectively
• Improve processes and efficiencies as necessary
• Gain a competitive advantage

What makes medical device QMS better than other QMS solutions?

To choose the best QMS solution for your medical device company you should:

– Consider the total cost of your QMS
Consider the time and resources it will take to manage quality management software made for medical devices vs. a general-purpose QMS tool. Keep in mind that a general-purpose QMS leaves more room for error. Errors can amount to huge business risks and increase the total cost of poor quality that your company is left to manage.

– Choose a QMS software that can support all stages of your medical device lifecycle
Managing design controls, risk, quality events, and more are all essential stages that occur throughout your product’s total lifecycle.

– Choose a QMS that can manage all activities within a closed-loop quality system
QMS software for medical devices that offers closed-loop quality system traceability supports its users by connecting the technology, people, and processes across all stages of the total product life cycle (TPLC), while also helping you meet regulatory requirements for your medical device.

– Choose a software partner with a proven track record
Always evaluate prospective QMS software vendors by investigating how frequently their software is validated, what their customer support policies entail, and how they manage and store customer data.