“The key advantage regarding quality systems is that they represent a preventive approach to assuring medical device quality versus the previous reactive approach by inspection and rejection at the end of the manufacturing line. Prevention has been proven to be more efficient and cost-effective in controlling manufacturing processes and maintaining medical device quality.”
This statement is part of Medical Device Regulations: Global Overview and Guiding Principles published by the World Health Organization in 2003, and it emphasizes the importance of prevention in assuring an effective and efficient QMS.
While we all agree on the importance of QMS in achieving company goals by ensuring that products consistently meet applicable regulatory requirements and product performance, safety, and efficacy claims, setting up the QMS early will help your company gain credibility with the FDA, customers, and potential acquirers. It will also help by avoiding high consultancy fees during the submission process because QMS systems include organizing your documentation, so you don’t need a consultant to piece information together.
Also, you should know that launching your first product without a QMS in place is illegal and can lead to failing your first audit.
What are the regulations that should be applied to avoid further sanctions?
In the US, the FDA is responsible for ensuring the safety and efficacy of products. Mainly, the core concepts of the regulation are the same for all medical products, but there are specific rules for some types of products.
Medical devices and in vitro diagnostic devices are overseen by the Center for Devices and Radiological Health (CDRH).
Current Good Manufacturing Practices (CGMPs) requirements for devices 21 CFR Part 820 is the primary minimum standard applicable to medical device companies that market and sell products in the US.
A “medical device” is defined by CDR as “any healthcare product that does not achieve its principal intended purposes by chemical action or by being metabolized.” Devices are therefore everything from tongue depressors to pacemakers, to MRIs and digital (app) therapeutics.
Getting your product certified as CE means that the device conforms to the health, safety, and protection standards outlined by the European Economic Area (EEA), and is granted by one of numerous possible authorized Notified Body agencies.
Your company has to contract with one of these Notified Bodies to complete ISO certification audits, such as ISO13485 Quality Management Systems for Medical Devices, and ISO 14971 Risk Management for Medical Devices, as well as to review and approve your device submission all before marketing it in an EU state.
If you wish to market your product in Canada, Health Canada is the regulatory body that ensures the safety of drugs and devices there.
Whereas the China Food and Drug Administration (CFDA) is responsible for supervising the safety of food, cosmetics, drugs, and devices in mainland China.
Many other countries have specific agencies for themselves as well. All regulatory organizations have guidance documents available on their websites.
International Organization for Standardization (ISO)
Compliance with applicable ISO standards is the first step in achieving compliance with European regulatory requirements. One of the regulations, ISO 13485, is a globally accepted standard (recognized by the FDA) and provides a way to comply with general quality management system requirements.
Demonstrating compliance to applicable international standards aids the FDA in evaluating whether your product was designed and developed according to the current best practices.
How do they regulate?
The FDA and international governmental agencies want companies to demonstrate the safety and efficacy of their products. So they first conduct inspections:
- The FDA inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations.
- Foreign manufacturing and processing sites for FDA-regulated products that are sold in the United States
They also evaluate Device Approvals, Denials, and Clearances:
- Premarket Notification
- Premarket Approval (PMA) decisions
You should note that the FDA has explicit requirements for various types of regulatory submissions before commercializing a product, as well as the various business processes included in your QMS.
How are Products Classified?
The classification of devices depends on the intended use of each device and its indications of use.
They are also classified based on their level of risk and categorized as Class I, Class II a, Class II b, or Class III, each with increasing risk, requirements, and scrutiny.
The device classification determines the type of submission required to market and sell it.
Regardless of the device classification, all medical devices/diagnostics are required to have a QMS (21 CFR Part 820) at the time of submission.
On a side note, the FDA has released on February 23, 2022, its proposed rule for the new Quality Management System Regulation (QMSR), which will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR), with the international consensus standard for medical device quality management systems, ISO 13485:2016. But it remains a proposed rule and there are several steps before its finalization.
Now that you have learned about QMS needs for ISO & FDA regulations, learn about Culture of Quality with ISO Standards.