Medical Device Manufacturing

/Medical Device Manufacturing

3 Key tools to mitigate ISO 11607 Package Design failure

As a project leader for medical device manufacturing, there is one area in particular that I feel can really derail projects.  When a project reaches me, often times the packaging has already been created and [...]

By | 2014-03-17T15:53:44+00:00 March 17th, 2014|LSO Blog, Medical Device Manufacturing, Medical Package Testing|

5 Project Management Rules for the Success of your Medical Device Launch

At LSO, we typically manage 50-55 new product launches a year. This doesn’t include helping existing customers with product revisions and follow on work.  This is a launch rate that far surpasses that of many [...]

Almost there… EtO Sterilization for Medical Devices

We are happy to announce that LSO is in the final phases of installation of two 8 cubic foot EtO sterilizers. We expect them to be certified and ready for production by the end of [...]

Medical Device Manufacturing: Quality Cheat sheet

Over the years LSO has worked with numerous start-ups – visionaries with innovative products and good business sense, but lacking knowledge on the intense amount of regulatory policies and procedures involved in manufacturing and getting [...]

By | 2013-06-06T21:59:27+00:00 June 6th, 2013|LSO Blog, Medical Device Manufacturing|

Offshoring vs Outsourcing: A world of Difference

There has always been much confusion when using the terms Offshoring and Outsourcing. Are they the same thing or different? How are they different? Which term applies in which instance?

By | 2013-05-17T17:28:33+00:00 May 17th, 2013|LSO Blog, Medical Device Manufacturing, Offshore Manufacturing|

Managing your Vendors

So how do you publish an article from the client’s perspective, without breaking any non-disclosure agreements? Well you find yourself an ex-client which has been acquired for $1.5 billion, and have them tell you about [...]

Boxed to Perfect Standards

The most critical factor for medical device packaging is product sterility, which must be maintained throughout distribution and storage, allowing for safe and effective use of the device. The primary standard governing medical device packaging and shelf life validation is ISO 11607-1

Biohazardous Returns Processing

Most medical device companies have product returns which are biohazardous. Some of these returns are biohazardous because hospitals didn’t follow their internal procedures, some are products that would have been disposed off by the hospital, but due to an issue in surgery they must be returned to the manufacturer, and some products are intended for reuse but must go through