Tag: Medical Device Consulting

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...
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Top Life Science Technology Vendors

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...
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Human Factors Engineering

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...
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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,...
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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...
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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...
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How to Structure a Medical Device Company

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....
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