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Medical devices change lives, but their potential depends on close regulation and proper use. To protect consumers, governments worldwide impose extensive legal restrictions on device manufacturers — and it's up to you to comply.
Implementing a medical device compliance consulting program is about more than simply learning the rules before bringing a new product to the market. Whether you're seeking FDA approval or a CE stamp under the EU's Medical Devices Regulation (MDR), you'll need a complete solution that lets you:
It's also worth noting that your FDA compliance burdens won't magically disappear when a product seems ready to ship. Before earning approvals, prosthetics, consumables, surgical implements, computerized systems, and software all need to undergo clinical evaluations. Manufacturers are also tasked with post-deployment monitoring and market surveillance. Depending on the nature of their devices, they may need to submit to specific forms of clinical trials and ongoing conformity assessments.
Some exempted low-risk medical devices, such as bandages and certain personal care items in the Class I tier, don't require FDA clearance to market. It's not always clear to manufacturers, however, where their products fall along the spectrum. Thanks to the complex realms of intended use, indications for use, and patient risk, device classifications often prove confusing at best.
Compliance is an inevitable hurdle — not only to get a device on the market but also to keep it in good standing. For instance, a Class II device might lose its exemption status if its manufacturer tweaks its operating features, fabrication techniques, or material composition. A patient incident or clinical failure might also expose you to increased scrutiny, making it imperative to be able to prove your good-faith efforts.
Although resources like the Code of Federal Regulations are excellent starting points for finding out where you stand, these dense legal frameworks take time and money to navigate. What's more, there's no guarantee that the in-house approach will save your enterprise from profit-killing regulatory crackdowns or the bad PR that comes with them.
Arbour Group makes it effortless to master medical device technology compliance without upending your business model. Our tools help you validate clinical applications and test devices under a broad range of operating conditions. Even more importantly, they generate the digital paper trails required to prove your governance efforts.
Partnering with Arbour Group empowers medical device fabricators to overcome the many complexities of FDA compliance. From auditing vendors and IT service partners to verifying data center compliance and conducting rigorous quality assurance testing, we help you create a viable roadmap to sustainable governance.
We work to guide manufacturers through the compliance process so that they can better meet the needs of clinicians, patients, and stakeholders. The Arbour team focuses on helping you establish quality agreements with partners and leverage insightful compliance analytics that reveal the costs and benefits of your chosen governance strategies. Our familiarity with hoops like 510(k) validation and 21 CFR Part 11 assessments empower your enterprise to put its technology offerings on the best possible footing from the start.
If you manufacture medical device technology, compliance isn't optional. If you're serious about running a successful enterprise, then finding a reliable Medical Device Technology consultant is just as essential. As regulations change, you need a dedicated partner to help you keep pace, and your organizational success is too valuable to gamble on uncertainties.
Talk to an Arbour Group specialist about medical device regulatory services that help your products meet the standards. No matter which market you cater to or how your enterprise contributes to advancing medical science, we can help you streamline compliance and serve the greater good.
Arbour Group is a trusted advisor to over 250 pharmaceutical, medical device and biotechnology companies worldwide. Let us demonstrate how we can integrate seamlessly into your organization, prove ourselves a valuable business partner and deliver effective services that reduce compliance costs.