Regulatory – Medical Alley Association

Regulatory

Leveraging Regulatory Expertise to Optimize Your Design Investment

How effective and early medical device strategy development can optimize your design and development process Written By: Marianna Gofman, Senior Consultant, IQVIA MedTech Regulatory Solutions Europe While continuous innovation supports new product design and development, it’s no wonder the healthcare industry is pressuring medical device companies to increase safety and efficiency, while also being innovative […]

The Value of Real World Evidence and Secondary Data in MedTech – Part 1 in a Series

Regulators’ Growing Adoption of Real World Evidence Brinda Sriskantha, PhD, Director, Real World Solutions, IQVIA MedTech and Michelle Bulliard, Vice President, Real World Solutions, IQVIA MedTech Regulators have been steadily increasing their use of real world evidence (RWE) to support decision-making. Simultaneously, access to real world data (RWD) continues to increase, and there’s growing clarity […]

5 Critical Areas for MedTech to Focus to Ensure Safety, Compliance, & Speed to Market

If 2020 taught us anything, it was that challenges bring innovation. We experienced resilience  as MedTech companies changed how they operate and began leveraging digital ways of working to accelerate the development and delivery of medical devices and diagnostics, while ensuring patient safety. These innovations have given way to long-lasting opportunities for medtech companies to […]

Regulatory Challenges in Writing EU MDR Compliant Clinical Evaluation Reports (CERs): What the Changes Could Mean for Your Products

This is the seventh in a series of blogs related to some of the key challenges being encountered to the recent updates to EU MDR. The New EU MDR Guidelines The new EU MDR guidelines will involve a lengthy EU MDR checklist including an array of topics, ranging from general administrative information to verification and validation, amongst […]

For The Record with Mark DuVal, President & CEO, DuVal & Associates, P.A.

Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies […]

Launching a Medtech Product? Have Your Regulatory, IP and Governance Affairs in Order Before Engaging Investors

By Walter Linder, Amy Judge-Prein, and Jonathan Zimmerman Investors in medtech companies are willing to take risks. However, they will expect their investment to be put to effective use with defined objectives, and their diligence will focus on identifying potential impediments to those objectives. Because momentum is important when seeking investment, it is critical that […]

FDA Grants Breakthrough Device Designation to Bio-Techne ExoDx™ Prostate Intelliscore™ (EPI) Test

MINNEAPOLIS, June 17, 2019 /PRNewswire/ — Bio-Techne today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its ExoDx Prostate IntelliScore (EPI) test, making it the first exosome-based liquid biopsy test to receive a Breakthrough Device Designation. This designation not only validates the clinical importance of Bio-Techne’s EPI test, […]

Medical Alley Association Statement on Announcement of FDA Commissioner Scott Gottlieb’s Resignation

FOR IMMEDIATE RELEASE: March 5, 2019 Medical Alley Association Statement on Announcement of FDA Commissioner Scott Gottlieb’s Resignation GOLDEN VALLEY, MN – The Medical Alley Association issued the following statement on the resignation of FDA Commissioner Scott Gottlieb: “The Medical Alley Association, on behalf of our 600 members that represent every sector of healthcare, thanks […]

The Future is Here: How Drones are Modernizing the Healthcare Industry

As use cases for drones continue to expand, industries whose connections to this technology were not obvious are now capturing headlines on a routine basis. The health and life sciences industry is an example of an emerging major player in the field. Delivering everything from blood and plasma to medication, defibrillators and condoms, drones are […]

Hearings of Interest

March 14, 2016 at 2:00 PM – Committee on State and Local Government Chair: Sen Patricia Torres Ray Room 2308 Minnesota Senate Bldg. Agenda: S.F. 2558  –  Sieben  –  Family and medical leave benefit insurance program; wage tax imposition; rulemaking; account creation; appropriation. March 15, 2016 at 2:45 PM –  Commerce and Regulatory Reform Chair: Rep. Joe Hoppe Room: […]

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