March 22, 2023
"The best time to plant a tree was 20 years ago. The second-best time is now"
Are you unsure of your companies' Quality needs? Well, perhaps today is the day to change that. Whatever you decide, don't begin thinking about Quality while you prepare your regulatory submission, as this will be too late!
Your QMS is a structured system that documents processes, procedures, and responsibilities for achieving quality policies and objectives and serves as a blueprint for how your device is brought to market. As a medical device company, documented processes and procedures to capture design, risk, suppliers, labeling, manufacturing, distribution, and many more aspects of your business are required.
Your QMS will contribute to the quality, safety, and effectiveness of your medical device, and will allow for the measurement of your ability to meet the needs of your customers.
For starters, it's the LAW.
Implementation and maintenance of a QMS is a condition of product registration in virtually all markets, including the USA, Canada & Europe.
Further, a QMS process is demonstrated to support safe medical devices. It also provides an opportunity to streamline your medical device operations.
Where would you like to sell your medical device?
Market selection is typically the first choice you need to make. Once you have selected your market(s) you can identify their unique QMS requirement.
Most of you will be looking at the US, Canada, or European markets. All these markets require the medical device company to have a QMS in place before the medical device is placed on the market.
Classify your medical device.
Now that you have identified your preferred market(s), there is another critical element required to fully understand your specific QMS needs.
You must define the class, (and Rule, if applicable) of your device using guidance available from your market's regulatory authority, or use a regulatory consultant if it is not immediately clear:
Manufacturers of medical devices classified as Class II, III, and IV in Canada must demonstrate compliance with ISO 13485 under the Medical Device Single Audit Program (MDSAP).
ISO 13485 is a globally harmonized, international standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer and applicable regulatory requirements.
MDSAP includes compliance with QMS requirements of the Canadian Medical Devices Regulations (CMDR) which may include additional QMS procedures and regulatory requirements beyond ISO 13485.
In the United States, a quality management system for medical devices is regulated by the Food and Drug Administration (FDA). FDA provides a framework of basic, non-prescriptive requirements for manufacturers in 21 CFR Part 820, the Quality System Regulation (QSR) for medical devices (soon to be the QMSR which will align closely with ISO 13485).
FDA defines a quality system as, "The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management." According to FDA, medical device manufacturers are required to develop a quality managment system that is consistent with the:
FDA Quality System Regulation (QSR) ensures that medical devices sold in the USA are both safe and effective for their intended use. The FDA maintains quality system regulations (QSR) that must be followed by all medical device manufacturers who wish to sell devices in the USA.
FDA quality management system requirements state that the manufacturer is responsible for creating their organization's policies based on the needs of the customer, business, perceived product risk, and requirements specific to the device and applicable regulations and standards.
The requirements for a European QMS are contained in Article 10 (9) of the Medical Device Regulation (MDR) 2017/745.
"The quality management system shall cover all parts and elements of a manufacturer's organization dealing with the quality of processes, procedures and devices..."
While not mandatory, a QMS compliant with ISO 13485 is extremely well aligned with the needs of the MDR. The EU MDR may include specific EU requirements that exceed the scope of ISO 13485 which you will need to address on a device specific case so that your QMS will be EU MDR compliant.
Maintaining compliance is critical.
Non-compliance occurs when your Quality Management System does not meet the established market requirements. Non-compliances can be minor (non-systemic) and easily rectified or they can be major (systemic).
The cost of non-compliance can be enormous; if the integrity of your QMS is compromised, it will jeopardize your business.
For the USA marketing, receiving a 483 letter is a point of concern expressed by the FDA about an area in your QMS that is not in compliance. FDA 483 letters are accessible by the public via the Freedom of Information Act. Consequently, the implications can be quite serious and should be treated as such. A detailed and thoughtful response within 15 calendar days is required to potentially avoid a warning letter.
Similarly, Health Canada issues a Notice of Non-Compliance (NNC) as a precursor to regulatory or warning letter. Failure to comply with a warning will result in enforcement action, from public safety alerts to establishment license suspension to prosecution.
Your Quality System should scale with your Medical Device Commercialization journey - just like the other aspects of the business - design, IP, regulatory, etc.
Take Koven's brief survey to determine if your QMS development is aligned with the other important aspects of your Commercialization journey
At Koven, we have first-hand experience in assisting medical device developers. We work together with you to incorporate the appropriate checks and balances associated with a medical device QMS. Each step in the developmental process benefits from an objective vantage point. That's where our expertise comes in. Contact one of our team members today.
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