Friday, April 20, 2012

Business Etiquette: 5 Rules That Matter Now | Inc.com http://ow.ly/apKFz
Basics that bear reminding!

Thursday, April 19, 2012

FDA: Safety, efficacy, public health – and economy? | MassDevice - Medical Device Industry News http://ow.ly/aoyzG

Wednesday, April 11, 2012

Hacker Shows Off Lethal Attack By Controlling Wireless Medical Device - Bloomberg http://ow.ly/aduCM

Tuesday, April 10, 2012

Is your product regulated by the FDA? Latest Blog Entry by Lean Compliance Partners! http://ow.ly/ac7Fx

Is your product regulated by the FDA?

What products come to mind when think of the FDA?


Based on commercials we see on TV, we most likely think of prescription drugs (for example, Humira, Zoloft, Cymbalta, just to name a few). Defribillators recently made the news via the CBS Sunday Morning segment "When Medical Implants Fail". aired on April 1, 2012. 


These examples are just one part of the FDA's mission. In actuality, the FDA regulates a wide range of products, from hospital beds to pet food. 


How do you know if the products you manufacture, service or import for sale within the USA are regulated by the FDA? 


The FDA has created a simple two-page questionnaire with yes/no questions that will help you determine if your product is regulated, and the relevant office you should contact you should contact with questions. FDA Basics for Industry is only a navigation guide - it should not be used as the final decision-making tool on the regulatory status of a product. Click here for an online version of the questions.


Please contact your nearest FDA Public Affairs Specialist or Small Business Representative for assistance on determination of regulatory status of your product. A directory of FDA offices in the field is available online.
What you need to know! FDA's 2012 Four Strategic Priorities for Ctr for Devices & Radiological Health. http://ow.ly/a7Cay

Thursday, April 5, 2012

FDA Regulations and Good Manufacturing Practice (GMP) is the focus of Lean Compliance Partners, LLC | PRLog

FDA Regulations and Good Manufacturing Practice (GMP) is the focus of Lean Compliance Partners, LLC | PRLog
¿Que Es Lean? Descubra los fundamentos de Lean, los requisitos del cliente y como liberar capacidad en sus operaciones. - YouTube http://ping.fm/brmT7
¿Que Es Lean? Descubra los fundamentos de Lean, los requisitos del cliente y como liberar capacidad en sus operaciones. http://ow.ly/a6toE
Food for thought: "Could the Device Tax Pull More than $2 Billion? Numbers To Assess Impact Vary Wildly | MDDI Medical Device and Diagnostic Industry News Products and Suppliers" http://ow.ly/a5I1g

Wednesday, April 4, 2012

What Is Lean? Discover the basics of lean, customer requirements and increasing capacity in your operations. - YouTube http://ow.ly/a5AeQ
FDA's China Offices Focus on Product Safety http://ow.ly/a5s1T

Tuesday, April 3, 2012

What Is Lean? on Vimeo http://ping.fm/uaZAs
What is Lean? - YouTube http://ow.ly/a44V0 Discover principles of lean through our introductory video. http://ping.fm/JZWGE

Monday, April 2, 2012

National Public Health Week | USA.gov http://ow.ly/a2wUF
http://ow.ly/a2wSA What to do to have fewer asthma attacks
The Small Business Social Media Cheat Sheet / Flowtown (@flowtown) http://ow.ly/a0XMx

Sunday, April 1, 2012

Check out our introduction to Lean principles presentation on SlideShare! http://ping.fm/b8HmY
When medical implants fail http://ping.fm/r1kV2 via @CBSNews

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