When is a Quality Management System (QMS) needed for Medical Devices?Ariel
When is a Quality Management System (QMS) needed for Medical Devices?
Medical device companies can often find it difficult to determine when to set up a Quality Management System (QMS). A large part of the challenge is in the prolonged time span required to fully establish a QMS which range can between three to nine months.
The right timing for deploying a QMS operation can vary greatly depending on three key factors:
- The region you wish to market your medical device
- Whether you plan to register a technology or bring a device to market
- The device classification type.
In this article, we review what a QMS is and how to determine when the right timing is to establish your company’s system.
Medical Device QMS: An Overview
What is a Quality Management System for Medical Device?
A QMS is a structured system for documenting the procedures and processes implemented throughout a part, or even the whole lifecycle of a medical device. It can cover a variety of aspects such as medical device design, manufacturing, supplier management, product labeling, storage & distribution, clinical data, risk management, and complaint handling. QMS standards are enforced in most of the world’s markets through ISO 13485: Quality Management System for Medical Devices, and the US FDA QSR: Quality System Regulation for Medical Devices.
Why is it Difficult to Determine When to Implement a QMS?
Typically, there is no formal requirement for a Quality Management System to be implemented from as early as the design and development stage. Many medical device developers in these early stages will work quickly to meet investor milestones or obtain an income through launching initial sales. Doing so, they sometimes don’t keep systematic records such as design controls or change management.
However, later on during regulatory submission of the device, they will need to demonstrate that from the beginning they had controls in place for developing the device. A Design History File (DHF) or a Technical file are prime examples. These requirements entail documentation of key aspects such as control of records, design history, basic SOP’s (Standard Operating Procedures), change control, and risk management. It is therefore imperative to maintain these records from early on, in order to be able to answer to any regulatory bodies challenging the device regulatory submission dossier.
The Partial QMS Approach
Even though a QMS will meet the requirements mentioned above, medical device development companies may find it best to hold off full QMS implementation until absolutely mandatory. That’s because especially in the very early stages of development, a full QMS can be burdensome and hinder the flexibility required.
The best approach, in this case, is to implement a partial (or pre-production) QMS, where only the most important parts of a QMS are implemented. This way companies can have a systematic method of handling the critical parts of medical device development, without being burdened by a complete Quality Management System. This results in having adequate controls and documentation from the start, creating a quality-oriented culture from early on in the project, and reducing the difficulty of implementing a full QMS in the future.
QMS Requirements for Different Regions
The US has its own set of regulations for medical device QMS, through the FDA QSR, or regulation 21 CFR Part 820. QSR proof of compliance is expected when companies go through the 510(K) process for a Class III medical device. However, the FDA will not require proof of QSR compliance at this stage for Class I and Class II devices, which is mandatory only after the device 510(K) process is complete and it is ready to be marketed in the US.
The Canadian Ministry of Health requires conformance to ISO 13485, certified through an auditing process called Medical Single Audit Program (MDSAP). This means that a full QMS is mandatory before you can get a license for marketing your medical device in Canada.
In Europe, obtaining CE Marking is mandatory for marketing medical devices, which means conforming to the new EU Medical Device Regulations. The easiest way for medical device companies to demonstrate conformance is through an ISO 13485 certification, resulting in the need for a QMS before submitting for a device market license.
Every big country such as China, Brazil, Japan, and others, has its own QMS requirements. In most cases, those are based on the ISO 13485 standard or the FDA QSR regulation. This means that companies can have a clear goal for setting an ISO compliant QMS system to cover every market. The only real challenge is when to implement it and to what degree, according to each specific case.
A Solution to QMS Considerations
Simply partnering with an established medical device manufacturing company can alleviate the hassle of establishing and maintaining your own QMS for medical devices. When working with Quasar, you gain access to a long established QMS with demonstrable efficiency, including standard operating procedures, ISO quality system, audits support, and documentation. This way you eliminate the learning curve of implementing and managing a QMS from scratch, reducing complexity and saving up on both time & resources.