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 is the Quality System Regulation?

FDA has identified in the Quality System (QS) regulation the essential elements that a quality system must embody, without prescribing specific ways to establish them. Because the QS regulation covers a broad spectrum of devices, production processes, etc., it allows some leeway for medical device manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement specific procedures tailored to their particular processes and devices. If you don’t fully understand 21 CFR Part 820 and how to apply it properly to your company, find a medical device regulatory consultant who does. Having experience in this area is critical to efficiently implementing compliance that supports your business goals.

Quality System Regulation 21 CFR Part 820 focuses on current good manufacturing processes (cGMP) and controls used for the design, packaging, labeling, storage, installation and servicing for all finished devices intended for human use. You should know that 21 CFR Part 820:

  • Is an FDA-mandated system of product design
  • Requires you to document the evolution of the life of your product
  • Applies a market-first product development focus
  • Requires a team-oriented approach to product commercialization
  • As a process, tends to challenge product design to the point of improvement

Compliance is a necessary expense; don’t put yourself in a position where it costs more in dollars or opportunity than it should. Take extra care early on to develop processes that, when followed, meet your compliance obligations in a way that supports your business goals and personality.

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