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Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release.
Sec. 820.30 Design controls. (a) General. (1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a) (2) of this section, shall establish and...
Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient.
I. REQUIREMENTS. § 820.30(a) General. (1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a) (2) of this section, shall establish and...
§ 820.30 Design controls. (a) General. (1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a) (2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.
Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.
For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § 820.1 - Scope. § 820.3 - Definitions. § 820.5 - Quality system. § 820.20 - Management responsibility. § 820.22 - Quality audit. § 820.25 - Personnel. § 820.30 - Design controls. § 820.40 - Document controls.