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Global Compliance for Medical Device Industry: Who needs Compliance to CFR, ISO13485, JPAL, D-MAH or 9100?

Medical device companies of all sizes face real challenges from emerging markets and international compliance. Many of the worlds regions are going through transformations where countries are making decisions to control their own destiny with respect to the standards and the requirements for regulatory compliance. Going, going, going gone are the days when other countries will accept the US standards and policies for managing the compliance or RAQA requirements.