Navigation Links
Cognition® Corporation Releases White Paper Upcoming EU Regulation of Medical Devices

Cognition® Corporation, a software company specializing in medical device compliance and commercialization, has just released a new white paper on the upcoming implementation of the European Union’s Medical Device Regulation (EU MDR).

The MDR is a new regulatory framework for the oversight of medical devices submitted to and cleared for market in European Union Member States. Intended to replace the previous Medical Device Directive established in 1993, this new regulation is set to see full implementation in May 2020.

“The transition to this new system of regulatory compliance is going to be a challenge for medical device manufacturers,” says David Cronin, CEO of Cognition Corporation. “We’re releasing this paper in the hopes of helping some organizations understand and prepare for the changes ahead in the European market.”

The new white paper takes a high-level approach to the EU MDR, laying out the basics before diving into certain preparatory methods manufacturers of medical devices can undertake. Strategies such as planning ahead, keeping an eye on device classification, and ensuring robust risk management are reviewed.

“There’s a lot happening with the EU MDR,” says Mr. Cronin, “and even though it was published back in 2017, there are still organizations who have yet to come into compliance before the official implementation date. By leveraging some of the methods we suggest in this new white paper, we believe that will go a long way in helping these manufacturers streamline the transition.”

Mr. Cronin adds that the paper will offer suggestions for meeting the MDR’s robust postmarket surveillance requirements as well. “Just like the FDA, the EU is getting more concerned with the total product lifecycle,” says Mr. Cronin. “By highlighting this in our paper, we hope to bring more awareness, and hopefully give folks a chance to better understand what the EU MDR is all about.”

The white paper is available for download here.

Cognition® Corporation, based in Lexington, Massachusetts, has offered solutions for product development compliance for more than fifteen years. Cognition offers the Cognition Cockpit® Platform, along with engineering and validation support, and industry expertise. Thousands of users worldwide use Cognition solutions to manage their product development process and meet regulatory, performance, and-time to-market goals. For more information, visit or call (781) 271-9300.

Read the full story at

Source: PRWeb
Copyright©2019 Vocus, Inc.
All rights reserved

Related medicine news :

1. Cognition® Announces Talks for Annual User Conference: NAVIGATE2019
2. Cognition® Corporation Releases Second Paper on ISO 13485
3. Elie Goldstein and Maria P. Falaschi Join New U Life Corporation® Executive Team
4. New U Life Corporation® Files Complaint at International Trade Commission Challenging Monopolistic BHB Patent Cartel
5. World-Class, International Field Announced for 2019 Colorado Classic® Presented by VF Corporation
6. Hard Money Florida Loans with Monroe Funding Corporation
7. E-9 Corporation Awarded Contract to Deliver Emergency Reporting Fire RMS and ePCR Solution for the U.S. Army
8. Atlantic Ultraviolet Corporation is Pleased to Announce the Development of its Digital Ultraviolet Monitor Line for Accurate and User-friendly UV-C Output Measurement
9. Food Bank of Delaware and Employees of Chesapeake Utilities Corporation Partner to Give Children and Families a Nutritious Start Back to School
10. ScoreData Corporation Announces Completion of Series Seed Financing
11. Talk with Cognition Corporation about Usability Engineering
Post Your Comments:
(Date:5/30/2020)... ... 2020 , ... Segal Trials, a privately held network of ... May, Mental Health Awareness Month, and May 20th, Clinical Trial Awareness Day, with ... their #StayConnected video series raising awareness of clinical trials and offering mental health ...
(Date:5/28/2020)... GREENWICH, Conn. (PRWEB) , ... May 28, 2020 ... ... addition of an important new 7th Donor Shield protection. Donors can now be ... of the Donor Shield program. The other six Donor Shield protections include lost ...
(Date:5/27/2020)... ... May 27, 2020 , ... Radiology Associates ... the United States, has aligned with the Strategic Radiology (SR) coalition of independent ... to join the SR coalition, which has 28 member practices in 20 different ...
(Date:5/26/2020)... ... ... Today TRC Companies (“ TRC ”) announced the release of its Back ... leaders assess whether their organizations are prepared to move forward as the country takes ... assist business leaders evaluate their readiness relative to CDC guidance and provides ideas for ...
(Date:5/21/2020)... ... May 21, 2020 , ... ... the CRC’s Guide to Coordinating Clinical Research, CenterWatch eLearning , ... The CRC Trainer: An Interactive Companion to the CRC’s Guide to Coordinating ...
Breaking Medicine News(10 mins):
(Date:5/28/2020)... ... May 28, 2020 , ... Escalating healthcare costs and ... leader and innovator in essential vision testing products, to launch web-based vision testing/screening. ... Testing has been released and considering the circumstances, could not be more timely. ...
(Date:5/27/2020)... ... 27, 2020 , ... Focus Technology , a leading provider of next-generation ... once again sponsor the American Heart Association’s 2020 Boston Heart Walk, earning ... year the firm is sponsoring the AHA event. The sponsorship donation will be used ...
(Date:5/26/2020)... ... May 26, 2020 , ... ... has acquired Open CoVIDx, the laboratory division of the Open Medicine Institute based ... Laboratories is Dr. Konstance Knox, the Virologist who previously co-founded what is now ...
Breaking Medicine Technology: