Medical Device Consulting - Methodsense, Inc

October 9, 2018
By Rita King
Company News, Medical Devices, Quality Management

Regulating Medical Devices Shapes Industry for the Better

This article originally appeared in Business Worldwide magazine. It’s fashionable to be anti-regulation in business today. But sometimes regulation is central to how a sector operates. We talk to Rita King, CEO of MethodSense and Russ King, President of MethodSense about why regulating medical devices and biotech/pharma companies is so critical. Most devices and innovations need to...

August 7, 2017
By Rita King
Company News

MethodSense Named Top 25 Life Science Technology Vendors

CIO Applications recognizes MethodSense as Top Life Science Technology Vendors Amidst technological innovations, regulatory changes, and increased reliance on patient-centric models, there seems to be a multitude of growth opportunities for life sciences companies. Life sciences undoubtedly remain one of the industries that see rapid technological evolution ahead of them. Even though life sciences has...

July 7, 2017
By Rita King
Company News

CV Magazine Names Regulatory Strategist Female CEO of the Year

Our CEO and Regulatory Strategist, Rita King, was recognized as Female CEO of the Year 2016 by CV Magazine. In addition to the award, CV Magazine conducted an in-depth interview with Rita to find out more about her success leading up to and in her current role at MethodSense. CV Magazine: Tell me about...

How the 21st Century Cures Act Impacts Medical Device Software

There has been a lot of discussion surrounding medical device software and how it should be regulated. Concern about software of this nature will continue to rise to the forefront of conversations because there will be an increasing number of these products in the marketplace. The 21st Century Cures Act specifically addresses which types of...

December 7, 2016
By Rita King
Human Factors, IEC 62366

Human Factors Engineering for Medical Devices

In February 2016, the FDA released a guidance entitled, “Applying Human Factors and Usability Engineering to Medical Devices.” The intention of this document, in combination with IEC 62366-1:2015 Part 1: Application of usability engineering to medical devices, is to maximize the safety and effectiveness of devices for intended users, use and use environments. Its purpose...

Improving FDA Reviews of Combination Products

Just a few short weeks ago, Robert Califf, the US Food and Drug Administration (FDA) Commissioner nominee, endorsed an internal report that provided recommendations on how the FDA could improve reviews of combination products. Combination products include: Products comprised of two or more regulated components, such as drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically,...

February 12, 2015
By Rita King
FDA 21 CFR Part 820, FDA Compliance, Quality Management

21 CFR Part 820 Ensures Your Device is Safe and Effective

An Early Practical Handle on 21 CFR Part 820 Improves Your Medical Device Business Operations The purpose of regulatory affairs is to ensure that your company complies with applicable laws and regulations. These regulations, such as Quality System Regulation 21 CFR Part 820, are intended to ensure devices entering the marketplace are safe and effective. What...

February 9, 2015
By Rita King
FDA 21 CFR Part 11, FDA 21 CFR Part 820, FDA Compliance

Meet FDA Requirements

Meet FDA Requirements for Medical Device Company Compliance Most medical device executives know they need FDA clearance to legally market and promote their product in the U.S. Beyond FDA approval, understanding how to effectively commercialize a medical device product means adapting to industry and legal expectations for operating as a medical device company. These expectations...

How to Structure a Medical Device Company

January 28, 2015
By Rita King
FDA Compliance, Medical Devices, Quality Management, Risk Management

How to Structure a New Medical Device Business

There’s More to Being a Medical Device Business than IP and R&D An emerging medical device business tends to focus their energy on product development and R&D. This is understandable because medical device founders are often first experienced innovators. As innovators, there’s a natural affinity to maintain a continued focus on product development and maturation....

Tag: Medical Device Consulting