FDA

Is Your ERP Ready for the Sunshine Act?

Don’t let the Sunshine Act final rule catch you off guard! The August 1st data collection deadline is just around the corner -- Strategic has a simple, fast solution for QAD users and customers using Concur On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) announced the release of the final rule implementing the [...]

July 18th, 2013|Categories: Blog|Tags: |

Is your ERP ready for the new Medical Device Excise Tax?

There’s no question that the new Medical Device Excise Tax (MDET) is going to involve cost, complexity and risk. Companies affected by the new MDET risk penalties, interest charges, additional transaction processing time and reconciliation costs to the extent that their systems and processes aren’t ready to cope with the regulation’s demands. Fortunately, medical [...]

November 20th, 2012|Categories: Blog|Tags: |

Top 10 ERP Needs for Medical Device Manufacturers

Medical device manufacturers operate in one of the world’s most highly regulated industries, where success can hinge on time-to-market, traceability, quality management and compliance with the latest regulatory requirements. Whether a company is a venture capital medical device start-up (VC medical device start-up) or a growth-oriented medical device company, it must follow closely controlled [...]

November 1st, 2012|Categories: Blog|Tags: |

Know Your FDA Reg’s and Manage Compliance

A recent edition of Medical Device Daily featured reporting on yet another medical device manufacturer that received a warning letter from the FDA for serious violations uncovered during an inspection. One of the most serious red-flag findings in the warning cited that the quality system had “never been reviewed for suitability or effectiveness.” The warning [...]

July 27th, 2012|Categories: Blog|Tags: |