How Strong Design Controls Simplify Compliance and Eliminate Audit Anxiety

Introduction

Achieving and maintaining regulatory compliance is an imposing hurdle for many medical device manufacturers. Missteps and inefficiencies addressing FDA, ISO, and other regulatory directives can result in costly delays, warning letters, and even business closure. FDA regulated manufacturers must establish and follow quality systems to ensure their products meet applicable requirements and specifications. More specifically, these manufacturers must establish effective design controls to demonstrate devices are safe and effective for their intended uses.

Quality Management Systems

For medical device companies that create sophisticated solutions with electrical, mechanical, and software components, adhering to quality standards throughout the new product development and introduction (NPDI) process requires a connected quality management system (QMS) methodology. This means having a QMS system that is connected to the product record and design process for optimal visibility and traceability throughout the entire product lifecycle. While seemingly obvious, many manufacturers continue to manage quality and product processes in disconnected silos, making it difficult for everyone involved in the NPDI process to work together. So it is crucial to use a single system for design control that connects teams, products, and quality to streamline regulatory compliance.

Design controls are at the heart of the FDA’s quality system regulation specified under Title 21 CFR Part 820 and ISO 13485. The FDA specifies the necessary steps and procedures for each design phase. These design controls govern the processes throughout NPDI. The FDA also defines how manufacturers demonstrate compliance. Medical device manufacturers must produce two pieces of compliance evidence—the design history file (DHF) and the device master record (DMR).

The difference between DHF and DMR can be confusing, particularly as medical device companies develop products in a more digital, and less paper-based world than when the FDA defined some of its foundational regulations and definitions. A key example is the question of where to place certain information such as specifications: as part of the DHF or the DMR? First, remember the FDA requires that manufacturers reference each record only once. Second, as the DMR is actually referenced by the DHF, all DMR content will be linked to the DHF and vice versa—an easy linking for any full product-centric QMS system. Therefore, companies can focus on logical positioning of the “questionable” records based on process flows. If a medical device company creates device specifications, labeling, packaging, or quality assurance procedures earlier in the design and development processes, the company can reference them in the DHF. Or, it can place these later in the DMR definition if created during the design output phase.