Put simply, ISO 13485 is a set of guidelines designed to define how you should manage your Quality Management System (QMS). Managing your management system may seem a little redundant, but this regulation exists for a reason.
Many medical device manufacturers use a QMS process that is a combination of paper-based processes and some general-purpose tools. Their quality processes are quite loosely held together by a small group of individuals in their company — usually document control personnel.
This disorganized approach leads to headaches, errors, and unnecessary delays for companies struggling to bring potentially life-changing devices to market. We were the first company to bring a web-based eQMS platform to life to solve this problem for growing life sciences companies, and we’re intimately aware of all aspects of ISO 13485.
We know that one of the biggest hurdles for most people in your position is to understand and implement the product realization requirements of ISO 13485:2016 and specifically, the complicated passages of its Section 7.
Bringing a medical device to market is an intense process filled with due diligence, engineering, and a lot of red tape. There are many steps in the process that will result in sleepless nights and a maybe even a few gray hairs.
While every step is important, the clinical trials that your device must pass are one of the most nerve-wracking and crucial pieces.
You’ve poured time, resources, and emotional energy into getting your device this far. So, it’s understandable that you may be reluctant to sit by the sidelines while your device is used for the first time in a trial.
However, many medical device manufacturers — big and small — are doing just that.
Contract Research Organizations (CROs) can monitor, audit, and manage your clinical trial from beginning to end and help you navigate the compliance challenges that await you. Your CRO's expertise can be invaluable to your clinical trials, especially if they have experience with devices in similar therapeutic areas and in the countries that you plan to market into.
With this process being so critical to the overall success of your device, how do you choose the right one? To start with, you need to learn what other regulations will impact your decision when you’re selecting a medical device CRO for your clinical trials.
Bringing a new medical device to market is not an easy process. To get this far, you’ve already made a significant investment in time and resources, and you still have a lot more work to do before you’re ready to launch.
The red tape you’ll have to get through is intimidating, and you need someone with experience to help you get through it without wasting resources and time that you don’t have to spare. You’re still engineering your new device, but now it’s time to start getting your systems up to snuff so you can pass inspection.
There are tons of medical device consulting services out there that can help you navigate all of the upcoming hurdles — but is hiring one a good choice for your company?
Ready to move on from a paper, hybrid, or legacy quality management system?
Quality management system (QMS) software built specifically for life sciences companies can be an asset which helps you comply with regulations and improve the quality culture of your organization.
Life sciences organizations are facing many pressures to get quality management right. Regulatory compliance is the top concern for FDA-regulated organizations, according to a recent study, followed by the need to succeed with cost control and achieve superior product traceability. A QMS explicitly designed for your industry and regulatory requirements can ease your compliance stress without the need for extensive configurations.
But how do you know a great life sciences QMS when you see one? What's the difference between a generic QMS which is only marketed as a vertical solution, and an eQMS designed specifically per cGMP, ISO, and other important standards?
With the right tools in place, you can move to the top of your market and grow your business. The right technology can align people and process to help you reduce regulatory risk, maintain an audit-ready state, and compete in tough market conditions. We’ll show you what a first-rate QMS for life sciences looks like by identifying a few key elements to search out.
If you’re losing sleep to nightmares about an unannounced FDA raid on your company, then it’s time to get proactive. You should be prepared for an audit at all times.
You are not the first medical device manufacturing company to worry about or face an FDA audit. Instead of laying awake at night, learn from others who have gone before you.
Make sure that you aren’t repeating your past mistakes or the mistakes of others. To help you, we’ve compiled this list of the most common mistakes companies make during an FDA audit along with our tips for avoiding them.
With the clock winding down, what does this new Medical Device Regulation (MDR) mean for you if you have previously approved devices or if you’re looking to bring new products to market?
As a medical device manufacturer distributing in the European Union (EU), the clock is ticking for you to transition from the decades-old Medical Device Directive (MDD) to the new MDR. The MDR came into force in May 2017 and provided a transition period for manufacturers of currently approved medical devices. You have until May of 2020 to fully transition over.
To help you prepare, we’ll answer some of the commonly asked questions about the EU Medical Device regulation timeline below.
Has your medical device company hit a sales slump?
It can be hard to focus on building your sales team when you’re testing a new market or getting ready to launch a new product.
A contract sales organization (CSO) might be just the solution to allow you to increase sales while you focus on more important tasks. They can fill in gaps, or you can fully outsource your sales team and the logistics needed to get them producing quickly. CSOs give you the flexibility to scale your sales force up and down as needed while helping you control your costs.
The question is, how do you evaluate a CSO to find the right partner? Let us show you six ways that you can assess potential CSOs to find the right one for your medical device company.
As a medical device company, you have more regulations and burdens than businesses in most other industries. You have an intense number of rules that you are required to follow to ensure that your devices meet defined standards. You also have the additional requirement of having to be able to demonstrate your compliance to Regulatory Authorities.
The Medical Devices Directive (MDD) gives manufacturers the ability to choose which conformity assessment you would like to use. While it may seem like having choices makes it easier, this is often confusing for new and seasoned medical device manufacturers alike.
Choosing the right conformity assessment will ensure that you get approval without wasting resources. Likewise, choosing the wrong assessment and failing approval will set back the launch of your product.
Because this choice is so critical to your overall success, you have to carefully consider your options and decide which is best for your company. To help, we'll explore the top considerations that will bring clarity into the right decision for your organization.
Are you worried that passing FDA regulations for your medical device are going to slow time-to-market and cause your team massive headaches?
Speed to market is an enormous competitive advantage for organizations in the device manufacturing vertical. Avoidable delays can result in hard and soft costs to your company, which include loss of competitive advantage or regulatory fines.
While the best eQMS and knowledge of regulatory requirements can help you comply with FDA cGMP, your organization may also opt for some expert assistance. Leaning on a consultant to guide you through the process can make things easier and provide peace of mind. We'll show you several strong options for FDA consultants who specialize in the medical device manufacturing industry so you can find the best fit for your company.
There are plenty of software providers that deliver the functionality needed to help you become 21 CFR Part 11 compliant. You can meet the FDA’s requirements for electronic records and signatures by using more than one software product.
However, achieving compliance isn’t maximizing value. To move to the top of your market and position your company for future growth, you don't need adequate compliance software—you need the best software for 21 CFR Part 11.
Don't simply ask, "Which platform can help me get the job done?" Ask, "Which platform will help me get the job done fast and keep my team productive?" FDA guidance on software for electronic records and signatures is very broad, which provides organizations with an opportunity to adopt compliant software for more excellent quality management. A compliance software could offer more benefits than just helping you avoid regulatory risks, such as better collaboration, smarter document control, or better data security.
While there’s no such thing as just one “best” software for every FDA-regulated organization, there are a few characteristics common among all of the leading options for 21 CFR Part 11 compliant software. Let's take a look at the features and qualities some of the most valuable options have to offer.