Examine the dynamic regulatory environment of drug-device combination products and provides concrete steps to take to navigate regulatory complexities and decrease time to market.
Explore the urgent need for businesses to adopt strong data integrity practices and identifies measures for how to achieve and sustain compliance.
Learn how Meta Biomed implemented a solution to accelerate digital transformation, improve collaboration in a reliable, secure, and scalable cloud environment, and more.
Learn how to significantly lighten the software validation load for your cloud environment system with these eight key practices.
Explore the FDA's e-transformation that promises to usher in a new era of electronic interactions between the agency and its constituents.
This brief provides an understanding of the roles corrective actions/preventive actions (CAPAs) serve in regulatory compliance and product quality improvement, offering a blueprint to help optimized strategies.
We outline the steps to take before, during and after an FDA inspection so the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario.
Materials not subjected to early testing can contain impurities/contaminants that impact downstream biocompatibility issues, which can increase the risk of regulatory hurdles.
Bring data into one place to gain end-to-end visibility and traceability for total quality in every stage of research, development and manufacturing.
Training defines the quality of the single most important asset of your organization: your employees. A good training management process serves as a preventative measure against poor quality.
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