Kapstone Medical


Recent Posts

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

May 15, 2020 / by Kapstone Medical

0 Comments

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

April 15, 2020 / by Kapstone Medical

0 Comments

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.” While these bad actors, sometimes referred to as “snake oil salesmen,” are still around, it is much harder for them to find a market for their products—all thanks to the FDA’s governance. 

European MDR: EUDAMED Database and UDI

January 16, 2020 / by Kapstone Medical posted in medical devices, MDR, Regulation EU, European Union, EU MDR

0 Comments

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.

European MDR: Post-Market Surveillance

January 8, 2020 / by Kapstone Medical posted in FDA, medical devices, MDR, Regulation EU, European Union, EU MDR, Post-Market Surveillance

0 Comments

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) that moves closer to the FDA’s approach.

The FDA defines PMS as the process of “active, systematic, scientifically valid collection, analysis and interpretation of data and other information about a marketed device.”

EU MDR: How Clinical Evidence Requirements Affect Medical Device Approvals

December 18, 2019 / by Kapstone Medical posted in medical devices, MDR, Regulation EU, European Union, EU MDR

0 Comments

Part 5 in a 7-part series on the EU’s Medical Device Regulation

Among the significant changes facing device makers transitioning their products in the European Union from the Medical Device Directives (MDD) to the Medical Device Regulation (MDR) are the new requirements around clinical evidence.

Under the MDR, device manufacturers marketing products in the EU will face some additional hurdles, but if you also market in the US, Canada, Japan, or other countries, the new regulations will likely be familiar to you.

European MDR: Product Portfolios and Technical Documentation

December 12, 2019 / by Kapstone Medical posted in medical devices, Regulatory, MDR, Regulation EU, European Union, EU MDR

0 Comments

Part 4 in our 7-part series on meeting the new requirements under the EU MDR

Complying with the European Union’s Medical Device Regulation (MDR) poses a daunting task for medical device makers marketing products inside the EU. One of the most taxing efforts for companies that already have CE-marked devices in the EU is the need for portfolio reviews.

European MDR: Notified Bodies

December 4, 2019 / by Kapstone Medical posted in medical device legislation, medical devices, MDR, Regulation EU, EU MDR

0 Comments

Part 3 in our 7-part series on meeting the new requirements under the EU MDR

If you are new to obtaining marketing approval in the European Union, the concept of Notified Bodies is one of the most significant differences from the US FDA system or regulatory oversight.

A Notified Body is an independent certification organization that is “notified” by an EU member state’s Competent Authority, usually the ministry of health, to certify that a product meets the applicable requirements for CE marking.

European MDR: How do we get ready for MDR?

November 21, 2019 / by Kapstone Medical posted in medical devices, Regulatory, MDR, Regulation EU, European Union

0 Comments

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

The new Medical Devices Regulation (2017/745/EU), or more commonly referred to as the EU MDR, poses significant challenges to medical device makers that want to market their products in the European Union.

The clock is already ticking and the three-year transition period is counting down to 26 May 2020, which is the “Date of Application” (DoA) of the Regulation.

What is European MDR and Why It happened, Timelines for Compliance

November 13, 2019 / by Kapstone Medical posted in medical devices, Product Development, Regulatory, MDR, Regulation EU, European Union

0 Comments

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

The European Parliament passed the Medical Device Regulation (MDR) two years ago and began a three-year transition period in May 2017 with enforcement set to begin in May 2020.

The new regulation repeals and replaces the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD), effectively pushing the reset button for medical device makers who sell products in Europe.

What You Missed Last Month – January Edition

February 4, 2019 / by Kapstone Medical posted in 3D Printing, Innovations, medical devices, AI

0 Comments

Artificial Intelligence and 3D Printing are making history in the medical device world. From AI manufacturing machines to the creation of 3D printed organs to more streamlined processes by the FDA to approve 3D medical devices. Here is a quick overview of what you missed:

Subscribe to Email Updates

Lists by Topic

see all

Posts by Topic

See all

Recent Posts