When it comes to getting regulatory approval, creativity is rarely, if ever, a good thing.
Medical device organizations have the opportunity to exercise innovation in product development and process improvement. However, creativity and innovation aren't the best approaches to take if you're creating a formal ISO 13485 Risk Management Plan.
A Risk Management Plan is intended to be a product-level document which identifies the risk activities that occur throughout your organization's product lifecycle. Risk management activities are intended to operate as living documents and receive updates each time your organization adopts new processes or controls against risk. The smartest approach you can take is simple—to create a document that's easy to use as part of your risk management file and update it frequently.
An ISO 13485 risk management document should address your organization's systems for applying policy and procedure to the various activities involved in analyzing, evaluating, controlling, and measuring risk throughout the product lifecycle. Each device is a little different, which can require some customization of this template format. However, we'll show you the major components of a great Risk Management Plan to get you started.
What's the difference between ISO 13485 and ISO 9001?
Do we need to adhere to both or just one of them?
Fortunately, you only need to worry about ISO 13485:2016 if you're going to make and distribute medical devices. To obtain a CE marking, which indicates conformity with safety standards for products sold in the European Economic Area, medical device manufacturers must either obtain a certification with a notified body or have a quality system in place.
ISO 13485 is a quality system for the medical device industry, and it effectively covers ISO 9001 with some additional requirements.
What many medical device manufacturers fail to realize, however, is that comparing ISO 9001 and ISO 13485 is a valuable exercise. By understanding the differences between these two standards, you learn where device manufacturers need to raise the bar on quality.
Achieving a quality-driven culture enables your organization to reduce unnecessary quality costs and regulatory risks, which means bringing better products to market faster.
However, to save time, money, and resources with QMS software, you need to choose the solution that fits your organization's needs. An electronic QMS (eQMS) should be right-sized to your organization's growth stage, budget, structure, and industry. Trying to adopt a QMS that doesn't fit your use case can lead to wasted cost, non-compliance, or costly software bloat from overly extensive configurations.
How do you know which QMS software can quickly provide a return on investment?
Understanding Current Good Manufacturing Practices (cGMP) in the pharmaceutical industry can, at first, seem like trying to pick up a handful of water. It's a broad concept that is hard to hold together.
The FDA currently offers 34 distinct final guidance documents for cGMP in the pharmaceutical industry, which include requirements for process validation, data integrity, quality metrics, and countless other topics.
The FDA's definition of cGMP is accurate. The information included in a final guidance document, which typically ranges from 10-30 pages long, is comprehensive but that doesn't mean it's clear. Reading cGMP guidelines provided by the regulatory agency can leave you with a lot of questions.
If you're wondering why "current" good manufacturing practices and why "quality by design" matters, you're not alone. In this post, we'll cover the official definition for these essential guidelines in terms you can understand with insights from pharma industry experts. Read on for some extra color and context on the definition of what cGMP is, why it's important, and how to achieve compliance in your organization.
The cost of quality in the medical device industry is probably even higher than you think.
The global impact of medical device quality assurance and failures is $36 billion, according to a recent study by McKinsey & Company, or between 7-9% of the industry's total sales revenue. Organizations collectively spend $12 billion on quality assurance and lose $24 billion on issues related to poor quality control.
Better quality assurance is a huge competitive advantage and an insurance policy against costly quality losses for organizations who are willing to invest.
Quality assurance training can improve skill and knowledge at your organization and allow you to take a more proactive approach to drive quality improvements throughout the medical device lifecycle. But how do you know which medical device QA training options are the best? As a team of medical device Quality Management System (QMS) specialists, we know which options are the most up-to-date and which are worth your time and financial investment.
In one recent year, nearly 83 percent of warning letters cited CAPA as an area of non-compliance at FDA-regulated organizations, although some organizations were noncompliant in one or more areas (such as CAPA and purchasing controls, or CAPA and process validation requirements).
It’s clear that organizations need a specialized software application for CAPA management, or an electronic quality management system (eQMS) with robust CAPA capabilities. In many cases where an organization received a warning letter, it’s likely that the technology was in place, but it failed for one reason or another.
How do you avoid getting stuck with a CAPA management software which leaves your organization open to costly regulatory risk or quality issues that can threaten patient safety?
There are eight key capabilities that separate great options from average or risky solutions when it comes to avoiding the risk of noncompliance with CFR 820. It’s crucial to keep these functions in mind if you’re looking for a new CAPA software or evaluating your current system.
Recent high-profile failures of medical devices have caused harm and injury to patients while damaging the FDA and medical device industry's reputations. In one of the most high-profile examples of medical device failure, tens of thousands of patients have reported debilitating injury after receiving a surgical mesh implant.
It’s clear something must be done to address patient safety risks.
Regulating medical devices using the same process and requirements as pharmaceuticals or biologics isn’t the right answer. Medical devices aren’t the same as prescription drugs. “If the FDA recalls pills, a patient can at least stop taking them immediately,” says Vanderbilt safety researcher Dr. Michael Matheny. However, “with implanted devices, patients are sort of stuck...and that's if surgeons can even safely remove them.”
At Qualio, we firmly stand behind the FDA’s plan to overhaul 510(k) and create new a new framework of requirements for device safety before market approval. Read on to learn why these impending changes are good for everyone, from manufacturers to patients, and how to prepare your organization for a successful clearance.
For life sciences companies, 21 CFR Part 11 compliance has always been a challenge. It requires irrefutable evidence that your organization is following FDA regulations. When these records were on paper, this was often a tedious process for companies. Thankfully, the FDA allows digital signatures and documentation that streamlines the compliance process.
However, even with the use of a Quality Management System (QMS) software, compliance for digital signatures and documentation for FDA 21 CFR Part 11 can still be complicated. You need to dot your i's and cross your t's while keeping your documents safe and secure. Your entire team needs to understand how to treat documents and signatures.
That’s why we recommend using a 21 CFR Part 11 compliance checklist to improve your processes. With our checklist, you can ensure that you’ve got the right systems and steps in place to maintain compliance.
Have you ever recommended a restaurant based on their lack of health violations?
"You should try Famous Fred's because they have a really good score with the health department!"
It doesn't happen.
It's similar to the difference between quality and compliance in product development. If Famous Fred simply tries to run a restaurant whose goal is not to get citations from the inspectors, he won't be in business long. He has to serve up delicious, quality food to his customers.
In the same way, life science companies must focus on producing high-quality products. If you aim for the high bar of quality, you'll get compliance. If you aim for the low bar of compliance, you probably won't get high quality.
Without a culture of quality in place, your employees may lose sight of how the devices they're building help the consumer. Meanwhile, your management team may focus too much on the budget and potential profitability. As a result, no one is focusing on quality.
For life sciences companies, an Enterprise Quality Management Software (eQMS) can be an asset or a liability. It all comes down to your ability to get more value from it than what you invest in it. If you choose a platform that’s too costly and isn’t the best fit for your organization, you won’t get what you need and spend too much.
That’s why to make the best investment, you need to understand how much an eQMS costs. When you know what goes into the price, and roughly what you should spend, given your industry and business phase, you can choose an eQMS that enables you to grow and scale your life science organization.