4 Questions to Ask Before Submitting a 510(k)

November 12, 2020 / by Kapstone Medical / 2 minute read

So you’re an inventor who wants to develop a medical device and use the invention in practice. You know the FDA regulates medical devices, but that’s about as far as your knowledge takes you.

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What is an ISO certification and what role does it play in the medical device industry?

November 12, 2020 / by John Kapitan / 5 minute read

In order to commercialize medical devices in accordance with international standards, medical device and development companies must be familiar with the guidelines set forth by the International Organization for Standards (ISO). Kapstone Medical is proud to have an ISO-certified quality management system (QMS)—but what does it mean to have an ISO certification? How would your company benefit from Kapstone’s expertise in this area? Read on for the answers, and please do not hesitate to get in touch with a Kapstone consultant if you have further questions.

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Explore the Changes to Medical Device Classification Under EU MDR

October 20, 2020 / by Kapstone Medical / 8 minute read

The European Medical Device Regulation (MDR) replaced the Medical Device Directive (MDD) in May of 2017. However, many medical device development companies are still working to understand the key differences between these guiding documents. Fundamentally, the MDR differs from the MDD in terms of device classification. Companies looking to commercialize their products in Europe will need to be familiar with these updated classifications and update their internal manufacturing, testing, and commercialization procedures accordingly. 

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Three Key Differences Between MDD and MDR

October 20, 2020 / by Kapstone Medical / 4 minute read

Adapting to The EU Medical Device Regulation (MDR)

Medical device companies hoping to bring their products to market in the EU will now have to comply with the Medical Device Regulation (MDR), an update from the old Medical Device Directive (MDD). Companies that were already compliant with the MDD will need to pay close attention to this updated regulation, which departs from the MDD in several key ways. 

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The Pro’s and Con’s of Medical Device Materials

September 14, 2020 / by Kapstone Medical / 5 minute read


Medical Device Material Selection: Pros and Cons Medical Device Companies Need to Know

Material selection is one of the most challenging—and important—components of medical device development. No matter how strong a concept or dedicated a team, selecting the wrong material can jeopardize a device’s commercialization timeline and likelihood of regulatory approval. Fortunately, the Kapstone team of experts is well-versed in device material selection and manufacturing as well as the testing needed to go with it. Our mission is to inspire, equip, and guide our partners in bringing the highest quality medical devices to market, which includes the material safety and effectiveness. 

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5 Ways Medical Device Development Companies Can Save Money When Developing Products

August 12, 2020 / by Kapstone Medical / 5 minute read

A Conversation With John Kapitan | Founder & CEO, Kapstone Medical

Medical device development companies large and small face different hurdles when bringing a new device to market. However, no matter their size, all companies cope with the inherent unpredictability of the development process—which, due to shifting regulatory guidance, the complexity of device manufacturing, and other factors, can quickly overwhelm timelines and budgets. 

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Using Competitor Research Throughout the Medical Device Product Development Lifecycle

May 26, 2020 / by Kapstone Medical / 6 minute read

A Conversation With David Walsh | Director of Engineering


According to David Walsh, Director of Engineering at Kapstone, medical device companies really only have one goal: to “make sure their device is ultimately widely accepted in the market, easily understood, and can be used safely and effectively.” Sums it up, doesn’t it?

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Solving The Top 4 Challenges Medical Device Companies Face When Developing New Products

May 15, 2020 / by Kapstone Medical / 5 minute read

A Conversation With Justin Rowland | Project Manager

Bringing a medical device to market is difficult for startup and established medical device companies alike. Though the development and approval process can sometimes take years, those years are jam-packed with requirements and milestones that can challenge even the most experienced companies.

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510(k) Premarket Notifications: How to Determine Substantial Equivalence

April 15, 2020 / by Kapstone Medical / 5 minute read

A Conversation with Kellen Hills | Regulatory Affairs Specialist, Kapstone Medical

Since 1906, the US Food and Drug Administration (more commonly known as the FDA) has protected consumers against the threat posed by adulterated, mislabeled, unsafe, or otherwise ineffective food and drug products. Regulatory affairs consultant Kellen Hills notes that before the FDA was empowered to regulate these products, “people were getting sick and dying because of unsavory characters putting things out on the market, making false claims about what they did with no oversight.” 

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How Outsourced Regulatory Affairs Consultation Can Save Your Medical Device Company Time and Money

March 31, 2020 / by Justin Rowland / 4 minute read

A Conversation with John Kapitan | Founder & CEO, Kapstone Medical

Bringing a medical device to market is a challenging process, to say the least. From ideation to product classification to obtaining final approval in a target market, so many of these necessary steps can become pain points for established and fledgling companies alike. 

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European MDR: EUDAMED Database and UDI

January 16, 2020 / by Kapstone Medical / 3 minute read

Part 7 in a 7-part series on the EU’s Medical Device Regulation

The European Database for Medical Devices (EUDAMED) was conceived 20 years ago in 1998, originally as part of the In Vitro Diagnostics Devices Directive (IVDD) and included the Medical Devices Directive (MDD).

Under the new MDR that replaces the MDD, the European Commission recognized that to fully support the more stringent requirements for filing, reporting, and continuing surveillance, it would need to greatly expand the capabilities of the database for monitoring and data collection.

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EU MDR and Post Market Surveillance: What You Need to Know

January 8, 2020 / by Kapstone Medical / 5 minute read

Part 6 in a 7-part series on the EU’s Medical Device Regulation

The new EU Medical Device Regulation (MDR) builds on the framework of the MDD with an increased emphasis on post-market surveillance (PMS) and post-market clinical follow-up (PMCF), similar to FDA’s approach for high risk devices.

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