Quality Management Systems (QMS) are a worldwide requirement for marketing medical device products. Often medical device companies new to the healthcare arena do not have the resources to develop a QMS or have a certified QA manager to implement and manage a validated system. To assist companies in meeting these requirements, we offer a QMS, which complies with both ISO 13485 and 21 CFR part 820 requirements.

CSSi LifeSciences provides clients a cost effective QMS that they can own.

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Our QMS Can Include:

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