![]() Why You Need An ISO 13485 Quality Manual For Medical Devices Read on to learn why a quality manual isn't optional, and essential components of this critical document for device manufacturers. A quality manual is a core component of ISO 13485 and many other quality management systems in highly regulated industries.Ī quality management manual guided by ISO 13485 can enable your organization to meet all applicable regulatory requirements, including FDA 21 CFR part 820, achieve certification with ISO 13485, and foster a culture of quality at your organization. The FDA guidance is closely related to ISO 13485 guidelines for medical device quality. ![]() That's the reason the FDA launched the Case for Quality program and 21 CFR part 820 designed for quality improvements among medical device manufacturers. Producing high-quality medical devices offers a clear benefit to both patients and manufacturers. Without a clear set of organizational guidelines, you may accept unnecessary risks of inspection or low-quality products. ![]() ![]() ![]() An electronic quality management system (eQMS) and a defined process for compliance are critical for medical device companies. ![]()
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