How Clinical Evidence Requirements Affect Medical Device Approvals

For Kapstone Medical

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. (published site)
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.
The big shift in the EU’s MDR is toward a much greater emphasis on ensuring a high level of health and safety protections for EU citizens.

Physician Tips: What Are Wearables and How Are They Used In Healthcare?

For Fibronostics

First in a series looking into the potential impact of wearable medical devices on healthcare

Drop the term wearable health devices and most people think of Fitbit or the Apple watch, but wearable health tech is much more than a new class of consumer products. (published site)

Product Portfolios and Technical Documentation

For Kapstone Medical
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. (published site)

Patients Achieve Significant Relief with Minimally Invasive PCF

For Advanced Orthopedics

Patients who underwent Posterior Cervical Fusion (PCF) and decompression obtained significant clinical improvement with high fusion rates and low revision and complication rates, and patient reported outcomes matched and, in some cases, exceeded the clinical results, according to a new study. (published site)

Physician Tips: Engagement Marketing For Improving Patient Compliance

Faced with performance-based reimbursement and growing pressure for improving outcomes, physicians are looking for ways to improve their patient communications and education in order to engage them and activate them for better health. (published site)

Notified Bodies

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.

How do we get ready for MDR?

For Kapstone Medical

High level areas to consider

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. (published site)