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What Is Medical Device Contract Manufacturing?

Medical device contract manufacturing is the outsourced fabrication of a medical device for the medical marketplace. The Food and Drug Administration (FDA) has very specific criteria to define a medical device.

By |2020-09-10T11:03:18-07:00September 10th, 2020|LSO Blog, Medical Device Manufacturing|

7 Recommendations for Sterilization Validation Integrity

Medical devices must be sterilized and prepared before use. There are several best practice and integrity recommendations to consider when your devices require sterilization, including cleaning and packaging.

By |2020-09-07T11:00:52-07:00July 14th, 2020|LSO Blog, Sterilization Validation Services|

Design Terminally Sterile Packaging: 3 Ways to Prevent ISO 11607 Package Design Failure (Infographic)

Your medical device product likely needs terminally sterile package design to deliver to market. At this point, you’ve progressed through product development and likely developed a sterilization process. You’ve now arrived at performance testing the sterile barrier system. But you may have concerns about the best way to evaluate your packaging system.

By |2020-09-03T08:33:18-07:00March 31st, 2020|LSO Blog, Medical Package Testing|

Designing Medical Devices to prevent Hospital Acquired Infections

According to the CDC, in American hospitals alone, hospital-acquired infections (H.A.I.) account for an estimated 1.7 million infections and 99,000 associated deaths each year (source).  A recent study in Emerging Infectious Diseases found that hospital-acquired [...]

By |2014-08-05T17:23:22-07:00August 5th, 2014|LSO Blog, Sterilization Validation Services|

Dye Penetration Testing – Recent ASTM Enhancements

Dye penetration testing is a common method of checking for seal leaks in medical packaging such as pouches, trays, and blisters. The intent of this article is to review and clarify the recent developments in [...]

By |2014-05-16T07:00:17-07:00May 16th, 2014|LSO Blog, Medical Package Testing|

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 [...]

Medical Device Tax – Something’s Got to Give

Theoretically, even though the tax will have a major negative initial impact on Medical Device companies, it will end up generating more business, due to the increased patient population having access to healthcare, and having procedures which require the use of medical devices. However, that is not likely to happen.

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 [...]

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