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The Advanced Medical Technology Association (AdvaMed) wants the U.S. Food and Drug Administration (FDA) to understand that medical device manufacturers need clarity on the FDA’s heightened focus on real-world evidence (RWE).

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The FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to medical device manufacturers.

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A common pitfall in quality management system (QMS) process automation occurs with a poorly planned process automation strategy. Too often, the temptation is to automate all quality processes at once and streamline the entire eQMS process in one giant undertaking. However, real-world experience has proven that this approach is just not feasible for long-term quality management success.

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Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.

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If compliance with the North American Electric Reliability Corp. (NERC) Reliability Standards wasn’t complex enough, registered utilities must also factor in the regulatory nuances of the bulk power system’s (BPS) eight regional entities (RE), even as NERC emerges with new risk management expectations.

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Life sciences companies around the world should make sure their corrective and preventive action (CAPA) plans are in good shape before a Food and Drug Administration (FDA) inspector comes calling. Looking at a deep pool of letters issued this year domestically and internationally, it’s clear the agency will focus like a laser on CAPA.

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(AssurX: Morgan Hill, CA) -- AssurX, Inc., a leading enterprise quality management, risk, and regulatory compliance solution provider, has released the latest update to its AssurX audit management software.

Key benefits to the organization
The AssurX software update keeps all stages of the audit process efficient and ensures important activities and issues are being handled properly and on time. The many features help organizations manage risk while meeting regulatory requirements and compliance.

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(AssurX: Morgan Hill, CA) -- AssurX Inc., an enterprise quality management, risk, and regulatory compliance solution provider, has released the latest update to its AssurX training management software.

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(AssurX: Morgan Hill. CA) -- ICF International and AssurX Inc., leading providers of consulting services and technology solutions, have announced a strategic partnership to provide comprehensive, outsourced management solutions for North American Electric Reliability Corp. (NERC) compliance for the energy and utilities industry.

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AssurX Inc. recently released CATSWeb Complaints Management & Regulatory Reporting System, its next-generation suite for the medical device manufacturing industry. A comprehensive solution, CATSWeb Complaints Management & Regulatory Reporting features solutions for business-performance evaluation and management dashboards, best-practices workflows, integration with other processes, audit trails and electronic signatures, and reportability-evaluation and regulatory reports.