4. Quality Systems and Design Controls

1. What is a Quality System?

A Quality System serves as the operational framework within a medical device company to ensure the safety and efficacy of its products. It is a structured set of procedures and processes used throughout the lifecycle of a product to achieve and maintain its quality. As a medical device company, it is mandatory to establish a Quality System that complies with regulatory standards like ISO 13485 and 21 CFR Part 820.

FDA Definition

According to the FDA, a quality system is "a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives."

Key Components in Regulatory Standards:

ISO 13485:

A globally recognized standard that outlines the requirements for a Quality Management System (QMS) specific to the medical devices industry. It focuses on quality assurance and risk management processes.

21 CFR Part 820:

This is the Code of Federal Regulations that outlines Quality System Regulations (QSR) in the United States. It is a comprehensive guide with different sections focusing on:

Subpart A - General Provisions
  • Scope: What the regulation covers.
  • Definitions: Clear definitions of what terms mean.
  • Quality System: An introduction to the requirements of a Quality Management System (QMS).
Subpart B - Quality System Requirements
  • Management Responsibility: Specifies who is responsible for what within the QMS.
  • Quality Audit: Internal checks to ensure quality is maintained.
  • Personnel: Staff qualifications and training requirements.
Subpart C - Design Controls (We will cover this in detail)
  • Design Controls: Guidelines and procedures that govern the design and development phase of medical devices. Covers aspects like design planning, input and output criteria, verification, validation, and design reviews.
Subpart D - Document Controls
  • Document Controls: Rules for how to handle documentation, from creation to storage and deletion.
Subpart E - Purchasing Controls
  • Purchasing Controls: Ensures that anything bought or contracted meets the required specifications.
Subpart F - Identification and Traceability
  • Identification: Requirements for marking and identifying devices.
  • Traceability: Ensuring each product can be tracked back to its origins.
Subpart G - Production and Process Controls
  • Production and Process Controls: Rules for the actual making of the medical device.
  • Inspection, Measuring, and Test Equipment: Guidelines for the types of equipment used in quality control.
  • Process Validation: Ensuring the production process consistently results in quality products.
Subpart H - Acceptance Activities
  • Receiving, In-Process, and Finished Device Acceptance: Standards the device must meet at various stages of production.
  • Acceptance Status: Documentation and criteria needed for a device to be considered acceptable.
Subpart I - Nonconforming Product
  • Nonconforming Product: How to handle items that don't meet quality standards.
Subpart J - Corrective and Preventive Action
  • Corrective and Preventive Action (CAPA): What to do when something goes wrong, and how to prevent future issues.
Subpart K - Labeling and Packaging Control
  • Device Labeling: Rules for how to label devices.
  • Device Packaging: Requirements for packaging to ensure safety and quality.
Subpart L - Handling, Storage, Distribution, and Installation
  • Handling: How products must be handled post-manufacturing.
  • Storage: Requirements for how products must be stored.
  • Distribution: Guidelines for how products are sent out.
  • Installation: Rules for how the product is set up at the user’s location.
Subpart M - Records
  • General Requirements: What documentation needs to be kept.
  • Device Master Record: A comprehensive file for each type of device.
  • Device History Record: Specifics about each batch or lot of devices.
  • Quality System Record: Overall documentation of the quality system.
  • Complaint Files: Records of customer or user complaints.
Subpart N - Servicing
  • Servicing: Requirements for maintenance and repair activities.
Subpart O - Statistical Techniques
  • Statistical Techniques: Guidance on using statistical methods for quality control and verification.

2. Design Controls

Sec. 820.30 Design Controls

Here is a summary of the FDA's Title 21, Part 820, Subpart C, which focuses on Design Controls in the realm of medical devices. It sets the rules for how medical devices, including their software, should be designed and maintained.

  1. General Rules: If you're working on software for a Class II or Class III device, or specific Class I devices, you have to have some control over how the design process works.

  2. Design and Development Plans: You need to have a game plan that describes what you're going to do and who's going to do it. This plan needs to be updated and approved as you go along.

  3. Design Input: "Design input" in this case are your requirements. What should the software do? What are the functional and non-functional requirements? Think of it as your software spec. You need to figure out what your software needs to do. This includes what the user and patient need. Any vague or conflicting requirements have to be clarified.

  4. Design Output: "Design output" is what you get after the design phase. Your design should be documented in a way that lets you check it against your initial requirements. You'll also need to identify key features that are critical for the device to function properly.

  5. Design Review: At various stages, you should sit down and review your design to make sure everything is going according to plan. These reviews should be formal and documented.

  6. Design Verification: After you think you've nailed the design, you have to test it to make sure it does what it's supposed to. This is like the debugging phase for software, as it checks if your 'Output' meets your 'Input' criteria.

  7. Design Validation: This is the ultimate test. You need to make sure your software works under real-world conditions. If your software is part of a medical device, this stage could include clinical trials.

  8. Design Transfer: Once the design is solid, there should be guidelines in place to make sure it's translated correctly into the final product. For software, it's not just about deploying the code; it's about ensuring that everything needed for the software to function properly in a real-world setting is correctly implemented. This might include final tests, quality assurance, setting up proper database architecture, or ensuring secure and compliant data storage.

  9. Design Changes: If you need to update or change your design, you have to go through a review process for those changes, much like version control in software development.

  10. Design History File: Keep all records related to the design process in one place. This is basically your project's paper trail, proving you followed all the rules.

So, from a software angle, think of this as a really stringent version of the software development life cycle you're probably already familiar with. You'll need extra documentation and reviews, plus special tests to make sure your software is up to medical standards.