FDA 21 CFR Part 820

Quality System Regulation (QRS) requirements are set up to ensure medical devices are high quality, safe and effective.

21 CFR Part 820 outlines the current good manufacturing practice (CGMP) guidelines for developing medical devices. It governs the methods, facilities and controls used for medical device design, manufacture, packaging, labeling, storage, installation and service.

Compliance with 21 CFR 820 and ISO 13485 Using MasterControl

Free Resources on Medical Device Compliance

QSR compliance is easier and more effective when quality is part of the business culture. Download these free resources to learn how to infuse quality into the organization.


How Medical Device Companies Can Meet QSR Requirements

The MasterControl Quality Excellence solution integrates all quality processes. Unify document control, training, change control, corrective and preventive action (CAPA), customer complaints and audit management. Also, automate design control and reduce the time and effort involved in maintaining your design history file (DHF).

Connected, Consistent, Complete and Compliant









What Is 21 CFR Part 820?

21 CFR Part 820 establishes the basic requirements for manufacturers of finished medical devices. It is designed to ensure devices are safe and effective and comply with the Federal Food, Drug and Cosmetic Act (FD&C Act).

How MasterControl Meets All Requirements of 21 CFR Part 820

Gain a competitive edge with the MasterControl Quality Excellence solution. Automate all quality processes. Comply with 21 CFR Part 820 requirements faster and get to market sooner.

  • MasterControl Documents™:

    Complies with subparts C, D, E, G by offering a real-time view of the quality system for continuous monitoring and improvement. MasterControl automates design control processes, which helps ensure your design history file (DHF) is complete and accurate. With this approach to maintaining the DHF you have a complete record of the design that's always available. This makes it easier to demonstrate that you followed the approved design plan, which can prevent possible product recalls.

  • MasterControl Training™:

    Complies with subpart B, section 820.25 by automating the management of all training processes. Easily route, follow-up and escalate training. Provide online exams, allow group sign off and automate sequencing of training tasks.

  • MasterControl Change Control™:

    Complies with subpart B, section 820.70 by automating every step in the change control processes. Achieve faster turnaround times. Customizable reports show real-time status of change control tasks and the entire quality system.

  • MasterControl CAPA™:

    Complies with subparts I, J by automating all CAPA processes. It integrates with other quality processes, such as document control, change control and audit. Allows for a holistic approach to quality management.

  • MasterControl Audit™:

    Complies with subpart B, section 820.22 by automating all audit processes. Simplify audit preparation, scheduling, issues, verification and completion. Reduces the time and effort needed to pass an audit.

  • MasterControl Customer Complaints™:

    Complies with Subpart M, section 820.198 by streamlining different steps and combining multiple sources of complaints under a single platform. It provides a configurable form that captures all necessary information and provides automatic follow-up notification to ensure timely responses.

  • MasterControl Nonconformance™:

    Complies with subpart I, section 820.90. It automates processes set up to identify, evaluate, review and handle nonconforming materials. This includes all components, parts and finished products.

Ease the burden of regulatory compliance.

Easily meet QSR requirements, improve efficiency and keep compliance costs down.

Download Your Free 21 CFR Part 820 Q&A Document
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