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meddevice.blogspot.com

Medical Device Blog: Latex Free Labeling Revisited

http://meddevice.blogspot.com/2013/06/latex-free-labeling-revisited.html

Jun 26, 2013. Latex Free Labeling Revisited. On April 23, 2013 the FDA issued draft guidance on the Use of ISO 10993, "BiologicalEvaluation of Medical Devices Part 1: Evaluation and Testing". This guidance document would finally supersede Blue Book Memorandum #G95-1 for medical devices. I won't go into much now, but it does include a section on Labeling Devices as "-Free" (such as Latex Free, DEHP Free, etc.) which I've cut and pasted below:. So there you have it. July 11, 2013 at 2:34 PM. Yes medical de...

meddevice.blogspot.com

Medical Device Blog: Good Intentions

http://meddevice.blogspot.com/2015/02/good-intentions.html

Feb 15, 2015. In The Road to Hell is paved with Good Intentions. A playground expert talks starts with a discussion about requiring helmets at all times and ties it into updated standards for playground surface and what happens in real life. Sometimes these things just don't work out like expected. On children wearing helmets:. The question arises then, what is the impact of using a safety helmet? April 26, 2015 at 11:55 AM. April 26, 2015 at 10:56 PM. May 20, 2015 at 4:49 AM. May 23, 2015 at 1:53 AM.

meddevice.blogspot.com

Medical Device Blog: Device companies deal with ACA

http://meddevice.blogspot.com/2013/10/device-companies-deal-with-aca.html

Oct 27, 2013. Device companies deal with ACA. QMED details how one medical device company is dealing with the 2.3% tax on medical devices imposed as part of Obamacare. Labels: medical device companies. Http:/ www.therewardologist.com/affordable-care-act-means-new-reporting-requirements-for-corporate-gifts/. February 7, 2014 at 3:40 PM. February 12, 2014 at 11:15 AM. Very interesting post and I knew maximum about the deals between Device companies and ACA. April 28, 2014 at 3:57 AM. June 2, 2014 at 3:02 AM.

meddevice.blogspot.com

Medical Device Blog: FDA Dysfunction

http://meddevice.blogspot.com/2014/04/fda-dysfunction.html

Apr 13, 2014. Has a post on the FDA and sunscreen:. In the Washington Post on the FDA and sunscreen:. 8230;American beachgoers will have to make do with sunscreens that dermatologists and cancer-research groups say are less effective and have changed little over the past decade. That’s because applications for the newer sunscreen ingredients have languished for years in the bureaucracy of the Food and Drug Administration, which must approve the products before they reach consumers. Or how about this:.

meddevice.blogspot.com

Medical Device Blog: New Links

http://meddevice.blogspot.com/2013/03/new-links.html

Mar 9, 2013. I've added Ford and Associates. To the links on the side. He has a blog covering mostly medical device quality and regulatory news, but the feed isn't working right for me at this time. I've also added a link to Knobbe Medical's Blog. Just FYI, I signed up as an Amazon associate, if you buy anything through one of the Amazon. Links on this site, I get a small percentage at no additional cost to you. Labels: medical device web. March 13, 2013 at 10:55 AM. April 19, 2013 at 3:20 PM. I enjoy re...

meddevice.blogspot.com

Medical Device Blog: Free pumps

http://meddevice.blogspot.com/2014/06/free-pumps.html

Jun 15, 2014. As part of the ACA insurance companies are now required to cover. The cost of a breast pump. Either a rental or a new one for you to keep. The FDA considers a breast pump a medical device. A breast pump and basic accessories will run you $150 to $300 with Medela. Seemingly the current most popular brand. As a consequence to the new law, if you check eBay or Craigslist you will find many breast pumps sealed in their boxes, available for sale below list price. Why? July 18, 2014 at 6:06 AM.

meddevice.blogspot.com

Medical Device Blog: Medtronic buying Covidien

http://meddevice.blogspot.com/2014/06/medtronic-buying-covidien.html

Jun 15, 2014. Big news in the medical device world. US medical device maker. Said on Sunday it had agreed to buy. For $42.9 billion in cash and stock and move its executive base to Ireland in the latest transaction aiming for lower corporate tax rates abroad. Entertainingly enough a few years ago Covidien bought ev3 (among others) and was still working on re-branding their products world wide, assuming they re-brand to Medtronic, at this rate, they'll never catch up. Labels: medical device companies.

meddevice.blogspot.com

Medical Device Blog: Excellence in Equipment Documentation

http://meddevice.blogspot.com/2013/10/excellence-in-equipment-documentation.html

Oct 13, 2013. Excellence in Equipment Documentation. Has an interesting post on Jake Breeden's. Which lists sacred cows in corporate life that we should reconsider:. Disguising indecision as a bland compromise that attempts to achieve many things but ends up accomplishing nothing. Creating a culture of learned helplessness with little individual empowerment and accountability. Spending too much energy producing perfect work instead of developing the quick-and-dirty solution needed now. Each manufacturer ...

meddevice.blogspot.com

Medical Device Blog: Blogs worth reading - creo Quality

http://meddevice.blogspot.com/2013/10/blogs-worth-reading-creo-quality.html

Oct 14, 2013. Blogs worth reading - creo Quality. Has a couple of excellent blog posts worth checking out, first off is Fast and Furious Medical Device Product Development. Read the blog to see where they are now. Second up is How DoYou Feel About FDA 510(k) Refuse to Accept? A couple weeks after submitting, I received a “refuse” response from FDA. The response included the RTA checklist with reviewer comments. I have never been part of a refuse to accept from the FDA, but this:. Diarrhea infection has s...