Quality Management and Compliance Standards for Med Device Manufacturers are Constantly Evolving – It’s Critical to Keep Pace with Quality
As the world struggles to come up with a treatment for the COVID-19 virus, it’s important to remember all the amazing innovations taking place in the medical device and life sciences world:
- Implantable devices, like one that measures things like elevated filling pressure and weakened ventricular contraction, enabling physicians to detect risk of heart failure weeks in advance.
- Ingestible devices, like a pill that moves through the digestive system, transmitting diagnostic information back to the doctor.
- 3D printers that can be used to create everything from custom prosthetics to artificial organs.
This marriage of medicine and technology has the possibility to change (and save) countless lives. However, there’s also the possibility of doing harm, something both manufacturers and patients want to avoid! That’s why we have regulations like those from the FDA as well as ISO standards, specifically ISO 13845.
As necessary as they are, however, they make the journey to market challenging.
Challenges facing medical device manufacturers
It’s an industry that’s both exciting and highly regulated. The need for regulation is obvious: A medical device that malfunctions has a much bigger impact than a cabinet door that won’t stay shut.
That’s why any medical device sold in the U.S. must have FDA approval. Additionally, meeting ISO standards gives your device credibility and is mandatory in some markets.
Getting a product to market
Health sciences companies have a very detailed path to follow before they can submit their product for FDA approval:
Lots of things happen once you submit your product to the FDA for approval, but let’s skip ahead to when your product is in the market. In some ways, your responsibilities are just beginning.
Monitoring a medical device that is in the market and in use
FDA regulations also mandate that you track and monitor your product while it’s in use. When you become aware of a potential problem, the industry standard is to implement a Corrective and Preventive Action (CAPA) process. These are the general guidelines, although they vary by company:
Medical devices can be extremely profitable, and they improve the lives of people around the world. However, they also bring an extremely high level of responsibility (and liability). The processes and the technology have moved beyond anything that can be controlled via a paper-based system; you need an automated quality management system.
How an automated Quality Management System gives medical device companies a competitive advantage
The winners in the medical device industry will be those who get to market first with a product that works — and keeps working. And it’s almost impossible to do that without an electronic quality management system (EQMS). Here are a few of the benefits an automated QMS provides:
Document control: A medical device without proper documentation is an accident (or audit) waiting to happen. An automated document control system can not only organize your documents so that you can find them when you need them; when you change a document tied to a particular product, they can also use automated workflows to make corresponding updates to any related documents.
Make collaboration easy: A QMS keeps track of everyone associated with a product — from the vendors who supply the raw materials to the folks who check quality on the plant floor. If there’s a nonconformance, a workflow automation can notify everyone involved that there’s all problem to solve and mitigate. It can get everyone in corrective action mode without wasting valuable time.
Proactively identifying problems: As more and more medical devices are IoT-enabled, a QMS software can monitor the information they generate and initiate proactive responses when there’s a nonconformance.
Vendor management: If a company requires their suppliers to meet certain criteria, the QMS can provide the platform for entering and updating information about the vendor’s own quality management.
The quality advantage
When you’re trying to get a new product to market, it’s easy to get so caught up in compliance that you forget about quality. If that happens, you can wind up with a medical device that may not hurt anybody but fails to serve the customers’ needs.
Using an automated QMS system can keep you on track when it comes to quality.
- Ease of use
- Displays that are easy to read
- Buttons and other controls that are easy to use
- Little need for training
- Doesn’t require customers to refer to a large user manual to solve a problem
That’s why using a QMS for medical device manufacturing is such a competitive advantage: You can build the steps for quality management right into the same workflows that help you navigate the intricacies of compliance.
And those are just a few of the ways an automated QMS like ETQ Reliance can help get your medical device to market quickly and maintain your product’s quality once it’s in use. Want to learn more? Schedule a demo, and we’ll be happy to walk you through the ways Reliance can benefit your organization.
