FDA Modifies Medical Device Labeling Requirements

After years of requiring most device manufacturers (besides IVD) to spell out the meaning of symbols within their labeling, FDA has issued a final rule that "allows the use of stand-alone symbols in medical devices without adjacent explanatory text". Previously, harmonized symbols recognized globally, such as "2" with a circle around it and slash through it

By | 2017-08-08T21:57:16+00:00 June 30th, 2016|Medical Device Information|

Leaders & Influencers: Robin Martin & Jana Gerken

In Fine Point Consulting's continuing series on Leaders & Influencers, they spoke with Robin Martin, Chief Regulatory Strategist, and Jana Gerken, Chief Legal Strategist, co-founders of the newly formed Kinetic Compliance Solutions, which provides regulatory and legal services to emerging and mature companies specializing in the medical device and life sciences industries. Here is a portion of the

By | 2017-08-08T21:56:42+00:00 June 30th, 2016|Kinetic Compliance News|

Celebrity Endorsements & the Law

A recent article entitled "Can Plaintiffs Sue a 'Celebrity Spokesperson'?" (see the below link) got me thinking about the interplay between the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) regarding celebrity endorsements. From the FTC (false and misleading advertising) perspective, a celebrity endorsement generally does not provide a basis for plaintiffs

By | 2017-08-08T21:55:48+00:00 June 28th, 2016|Compliance Updates & Legal Info|

Wisconsin women share stories of entrepreneurial success

Kinetic Compliance Solutions was proud to be represented as part of a recent panel discussion on women in entrepreneurship at the 2016 Wisconsin Entrepreneurs' Conference organized by the Wisconsin Technology Council. Erik Lorenzsonn of The Capital Times covered the panel and discussion. Read the full article here.

By | 2017-08-08T21:56:06+00:00 June 28th, 2016|Events|

Five Key Principles to Help Emerging Companies Succeed

Here you are - you’ve got this great idea, this innovation or thing that will change the world, revolutionize an industry, or otherwise positively disrupt the status quo. Now what? Here are five key principles to help you succeed in getting your idea to market: Work with the right advisors Protect your intellectual property Form

By | 2017-08-08T21:57:03+00:00 June 1st, 2016|Managing Risk|