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A guest post by Bob Hartwig, formerly a Stratos Product Development Project Manager. Import duties and fees getting killing your budget? Don’t let the daunting complexity of import get you down! Today’s laws regarding importing merchandise into the U...
If you ask “how much less documentation is required for the design of a Class 1 device compared with a Class 2 device?” you get a very different answer. Instead of 0% (Yes a DHF is required) of 100% (No DHF required), the answer is that you need 33% ...
HealthLink Dimensions asked 787 physicians and nurse practitioners what information they want to receive from you. This is what they said: http://medgroup.biz/what-docs-want In the report you will discover: • How to engage with healthcare professiona...
10x faculty member Aaron Joseph believes agile methods can almost universally be appropriate for medical device software development. Yet he finds relatively few medical device manufacturers have adopted the methodology. Why? Aaron says, "There's a m...
Looking through the Final text of the EU MDR, it's obvious that although the familiar rules based classifications, risk based review and 3rd party conformity assessment remain, there's a whole lot of New and the bar is raised much higher. There are m...
Most regulatory experts work on medical device OR in vitro diagnostics--not both. Making the switch from one type of 510(k) to another is not that hard.First, the submission content and format requirements are the same. There are still 20 sections, a...
"Nobody knew that health care could be so complicated," President Trump conceded last week. He should have asked members of the Medical Devices Group! Many of you are intimately familiar with the complexities of the U.S. health care system. As you kn...
Raising Early Stage Investments was a panel topic at the Medtech Showcase in January. Among the points that caught my ear: • Joseph Gulfo: When you raise public money, ask (1) What is the maximum percent of a company the investor can own and (2) What...
Over the years, a number of trucking, shipping, and delivery companies have asked me how they can get a foot in the door of medical device companies. And this week a group member asked, "What do the top medical device companies do to warehouse their ...
Jedrzej Kocinski
Assistan Professor (dr hab.) w Uniwersytet im. Adama Mickiewicza w Poznaniu
February 2017
As far as I know it is not obligatory to have one to get 510(k) cleared in FDA. There are no medical devices on OSHA list. However most of the people say that it is necessary in practice, because hospitals and other institutions do not want to use d...
