Category: Minnetronix Medical

When most people think about FDA clearance, they often picture paperwork and a lengthy approvals process–complete with clinical data and guidance documents. While these facets of FDA approval for medical devices are crucial, there are some measures that can expedite the process. Minnetronix, in particular, secures FDA approval with careful design.

Designing for Medical Device Regulations

It can be easy for regulations to be relegated to the end of the design process. Many medical device manufacturers fail to account for FDA requirements early in the process and must scramble to alter their product right before production. These efforts to minimally alter the function of the device, while adhering to regulations, can result in unforeseen costs, labor, and coordination. One of the best ways how to get approval for medical devices is to design with FDA clearance in mind.

Priorities for Medical Equipment Manufacturers

Minnetronix understands that a medical device has some priorities that take precedence over others. Any medical device company will emphasize three characteristics for their product, without wanting to make sacrifices:

• Usability – Medical devices need to be usable, without compromise. FDA regulations won’t have a heavy effect on a product if it’s unusable. Some designers, however, struggle to emphasize a product’s usability while accommodating FDA clearance.
• Function – Function is everything for a medical device. When FDA guidelines force you to make changes to your product, it can be difficult to preserve the function of your product.
• Performance – Your organization will have clear goals for the performance of your product. Altering the performance level of your device should not be the solution for getting FDA approval for medical devices.

Relying on Minnetronix for FDA Clearance

For full lifecycle solutions, you can rely on Minnetronix. These full lifecycle solutions include our expertise in design and development. You can rely on our skilled teams of engineers and scientists to help you build a product that’s maximized for usability, function, and performance. In addition to design that adheres to FDA regulations, your final design will also allow for efficient manufacturing. To get started, and accelerate your next breakthrough, contact Minnetronix for more information.

Compliance is a term you’ve undoubtedly heard of in the medical field. New technology in medicine must conform to regulations and standards in the industry. Medical device compliance is multi-faceted and can require expertise from an outside source. For many organizations, relying on an expert may be necessary to bring products to market quickly while remaining cost-efficient.

What is Medical Device Compliance?

Medical device compliance has many aspects and can quickly become complicated. But in general terms, compliance ensures that processes and procedures meet the required industry standards and regulations for a device. Compliance also involves describing the company’s practice for executing any processes and ensuring that employees are trained to follow said processes.

When trying to ensure compliance, medical device manufacturers must be aware of the regulations that apply to the device in question. This is not always an easy task because these regulations vary depending on the intended market for the device. Regulations can also vary at the national and international levels, presenting more complications for manufacturers.

Solving Medical Device Compliance Issues

Before you can begin solving medical device compliance issues, you’ll need to know if you have the resources to do so. A lack of staff, expertise, time, or money may prevent an organization from moving quickly to solve compliance issues. Having the proper resources in place to evaluate compliance leads to important information that will affect the product.

Committing the proper resources can translate the data you gather at this stage into many necessary pieces of information. This information includes company governing procedures, device design requirements and specifications, and manufacturing requirements and processes. All of these will drastically alter your product, so contributing resources to discover compliance issues is critical.

There is also the issue of varying compliance requirements. Some of the most difficult compliance problems to navigate for device makers are the updated EU MDR requirements and many non-US country regulations. For medical devices made with hopes for worldwide distribution, these regulations increase the rigor required to obtain approval before doing so. This compliance issue can cause serious impediments–requiring time and money as organizations attempt to bring a product to market.

But perhaps one of the most challenging aspects of compliance is maintaining regulations throughout a product’s lifespan.

Keeping Compliance Across a Product’s Lifespan

Maintaining medical device compliance across the lifespan of a product can seem impossible. After a product has been brought to market, compliance shifts towards post-market activities. These post-market activities include additional surveillance activities, reportability activities, compliance maintenance from the manufacturer, and investigation into customer feedback.

Any organization that doesn’t meet shifts in compliance can quickly find themselves in a bind. Without the proper knowledge of shifting regulations, medical devices that were once a valuable asset can quickly become a drain on time and money.

Keeping compliance can seem impossible without a team dedicated to it. Minnetronix functions as a partner for Full Lifecycle Solutions, including the compliance stage in medical device development. Our skilled teams use a wealth of clinical experience to clear a path to regulatory approval and bring products to fruition. For more information on what Minnetronix can do for your organization, contact us today and accelerate your next breakthrough.