Tag: FDA QS Regulation

Implement 21 CFR Part 820 Controls Early On

Benefits and Risks of Moving to the Cloud Migrating to the Cloud: What are the Benefits? According to the National Institute of Standards and Technology, the cloud is “a model for enabling convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly...
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21 CFR Part 820 Ensures Your Device is Safe and Effective

An Early Practical Handle on 21 CFR Part 820 Improves Your Medical Device Business Operations The purpose of regulatory affairs is to ensure that your company complies with applicable laws and regulations. These regulations, such as Quality System Regulation 21 CFR Part 820, are intended to ensure devices entering the marketplace are safe and effective. What...
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