11 Free Resources to Boost Your Medical Device FDA Readiness

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Toolkit 1 1 FDA Readiness Toolkit for Medical Device Companies Quality standards are defined by governing entities like the FDA in order to promote and sustain the quality of medical devices manufactured throughout the world. The guidelines set forth by the FDA are a major factor in ensuring that companies manufacture and sell medical devices that are safe, reliable, and effective. Whether they do it effectively or not, complying with these regulatory guidelines is simply a normal part of doing business for medical device manufacturers. MasterControl, a global provider of enterprise quality management software (EQMS) solutions, has invested over 360 expert hours into the creation of this FDA Readiness Toolkit that is designed to help medical device manufacturers simplify compliance with FDA standards and streamline quality- related processes. FDA Just Called! Now What? Regulatory gurus Linda Chatwin and Walt Murray explain what needs to be done to maintain a continual state of regulatory readiness. They walk through the steps that should be taken when the FDA schedules an inspection, and even what to do when inspectors show up unannounced. How a Med Dev Company Uses the MasterControl EQMS Learn how ReliantHeart, a medical device company, utilizes the MasterControl Training™ solution to avoid training issues that can lead to non-compliance with FDA regulations. According to ReliantHeart's Chief Operating Officer (COO), Anthony Williams, "MasterControl is known by the FDA and that's a huge advantage." Passing Audits and Inspections with MasterControl MasterControl customers tell how the solution simplifies audit processes, impresses auditors, relieves audit concerns, and gives them a competitive edge. FDA Readiness Toolkit Videos:

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