This infographic goes through 5 key questions to go through in order to control your budget.
This piece discusses 10 key strategies to building an efficient regulatory writing process.
This report clarifies the modifications to the equivalence guidelines in MEDDEV 2.7/1 and Quality Management Systems (QMS) ISO 13485 standard to help develop strategies for compliance.
The changes to 2.7/1 rev. 4 suggest the need to submit more frequent CERs to regulatory authorities, however, strategies will be discussed for managing the increased requirements
This gap analysis addresses key revisions to evaluator qualifications and scientific validity in the Clinical Evaluation (CE) MEDDEV guideline rev.4.
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