In the world of compliance, there are a lot of stakes. Food and Drug Administration (FDA), the teacher, in this case, can provide you with the correct answers. 

It doesn’t mean that 21 CFR Part 820 will be easy to follow. There are different challenges. Companies that lead the medical device market don’t have all the knowledge—they are successful because they implement the knowledge. 

The internet is full of information. What makes a medical device company excel is its ability to grasp it all and execute, understanding the big picture (What does 21 CFR Part 820 cover? What is it for?) and the granular details (How is an approved supplier list compiled?). 

Through this in-depth and easy-to-understand guide, you will gain a comprehensive understanding of 21 CFR Part 820 as it explains the regulations step-by-step. Throughout the manual, you’ll find answers to several questions mentioned above and specific instructions on how to comply, as well as common errors manufacturers, make so that you can stay out of trouble. 

Before we dive into the details of adherence to the quality system regulation for medical devices, let’s review the basics of 21 CFR Part 820. 

A brief overview of 21 CFR 820 

Medical device manufacturers must adhere to the FDA’s (CGMP) regulations as part of their quality management system as outlined under 21 CFR Part 820. An enterprise quality management system ensures that medical device companies deliver safe, effective, and compliant products. 

To summarize, 21 CFR Part 820 regulates “every aspect of human-use devices, including their design, manufacture, packaging, labeling, storage, installation, and maintenance,” as well as their facilities and designs. 

What is the FDA’s 21 CFR PART 820 requirements for quality systems? (And how to comply with them?) 

FDA’s 21 CFR PART 820 requirements for quality systems are divided into multiple subparts, including: 

1. 21 CFR Part 820 Subpart B—Quality System Requirements 

The 21 CFR Subpart B has three primary sections. Section one discusses management responsibilities, which include creating policies, resources, performing reviews, and planning. Quality audits are covered in the second section, while compliance with regulatory requirements is dealt with in the third section.  

The only way to comply with all three sections is to have quality management software that manages quality documents, conducts regular audits so you can improve continuously, and helps train employees on compliance best practices. Furthermore, it will help you create a culture of quality where quality is everyone’s responsibility. Such a culture encourages quality teams to manage quality and compliance risks proactively. 

2. 21 CFR Part 820 Subpart C—Design Controls 

21 CFR Part 820 Subpart C includes the requirements for the design process, including – planning, designing, review, verification, validation, change management, and maintaining design history records. The most common mistake observed in the designing processes is that organizations delay creating design controls. This further keeps them from collecting the relevant data. 

To comply with the requirements of the design process, organizations should identify the pattern of critical processes and create workflows accordingly. It will help them collect the necessary data on time to further utilize for planning and decision making. A QMS can, however, allow you to configure workflows based on your business requirements. 

3. 21 CFR Part 820 Subpart D—Document Controls 

21 CFR Part 820 Subpart D relates to document controls that quality managers use to manage documents throughout the product lifecycle for medical devices. Document control includes establishing procedures for creating controlled documents, reviews, approvals, distribution, and change management. The inability to manage controlled documents can put businesses at compliance risk. 

The best escape here is an electronic document management system to simplify document control processes for you. The software will help your teams to manage documentation-related processes proactively while ensuring organization-wide distribution of the same documents on time. In addition, you can easily find a DMS that supports digital signatures for meeting compliance. 

4. 21 CFR Part 820 Subpart E—Purchasing Controls 

Controls for purchasing are discussed in 21 CFR Part 820 Subpart E. It guides about evaluating suppliers, contractors, and consultants, as well as obtaining purchasing records. The most overlooked mistake companies make is not assessing their suppliers appropriately. Subpart E outlines the requirements for supplier qualifications that need to be evaluated precisely before the onboarding process. 

Therefore, companies should take supplier quality management more seriously. They can implement Supplier Quality Management Software that helps them to streamline all the supplier-related processes, including selection, onboarding, and auditing. Using the software, you can also create and update your approved supplier list at regular intervals to ensure you are doing business with suitable suppliers. 

5. 21 CFR Part 820 Subpart F—Identification and Traceability 

A crucial part of 21 CFR 820 is Subpart F, which describes identification and traceability. In the context of identification, it means avoiding product “mistakes”; in the context of traceability, it means tracing defects back to their source. Unfortunately, medical device companies often find it challenging to create a closed-loop quality system due to decentralized and disparate systems that impact traceability. 

The best solution here is an integrated quality management solution that can help medical device companies to create a closed-loop quality system. It will help them identify and manage inconsistencies in the system efficiently. Also, the software with a centralized platform will improve traceability of the quality issues to resolve them as soon as possible. 

6. 21 CFR Part 820 Subpart G—Production and Process Controls 

The 21 CFR part 820 subpart G focuses on production and process controls. These controls include inspection, gauging, testing equipment (calibration and maintenance), and process validation. The key challenge here is creating a validated system for inspection, calibration, and maintenance processes so you can deliver the best quality products every single time. 

If creating validated processes and systems sounds like a tedious job, you must upgrade to next-generation quality management software that can help you create repeatable processes for inspection, calibration, and maintenance. It will help ensure quality at every stage of production without any hassles. To put it simply, you can standardize the production and process controls with the suitable QMS. 

Related Article: How Cloud QMS Simplifies Process Validation?

7. 21 CFR Part 820 Subpart H—Acceptance Activities 

Under part 820, subpart H, acceptance activities are described. This includes acceptance of the receiving, in-process, and completed devices, as well as the regulations for approval. The mistake that companies make here is not having a standardized inspection management system in place. A formalized system can help identify the nonconforming materials as well as material reinspection needs. 

Inspections can be very challenging to manage manually. It would be best to implement Inspection Management Software to streamline all the inspection-related processes. The software will help you generate reports quickly to identify trends and make informed decisions. Inspection management software automatically stores all the relevant information for quick future reference. 

8. 21 CFR Part 820 Subpart I—Nonconforming Product 

Part 820 of the 21 CFR relates to nonconforming products. The process includes the control of nonconforming products through review, disposition, and rework. The medical devise companies often face challenges at setting up adequate procedures to manage product and process nonconformances. It becomes important to identify nonconformances and resolve them in a timely manner. 

At this point, companies would find a nonconformance management software useful. The software will help streamline nonconformance workflow to properly contain, dispose, investigate, and resolve defects and deviations. The next generation nonconformance management system also helps meeting compliance with applicable regulatory compliance. Handling nonconformances correctly can make a world of difference for your brand reputation. 

9. 21 CFR Part 820 Subpart J—Corrective and Preventive Action (CAPA) 

In Subpart J of 21 CFR Part 820, we talk about corrective and preventive action, also known as CAPA. CAPA is a method for addressing structural flaws in the manufacturing process of medical devices. The most common issue with managing CAPA’s is categorizing events since all the quality issues cannot be dealt with as CAPA. 

For a holistic approach towards quality issues, medical device companies can use powerful CAPA management software. The software can help perform a risk assessment and analysis to identify root causes and develop an effective action plan accordingly. Using the software, you need not worry about documentation since it automatically records all the CAPA details. 

10. 21 CFR Part 820 Subpart K—Labeling and Packaging Control 

Part 820 Subpart K of the 21 CFR lays out requirements for labeling and packaging. It covers labels, inspection, storage, and operations. But, unfortunately, the most common mistake companies make is applying blanket rules for labeling the devices. And, this could lead to severe consequences, especially when a device requires sterilization. 

Companies should highlight the critical information on labels as prescribed in the FDA guidelines for proper packaging and labeling. In addition, the companies can educate and train their staff on the importance of correct labeling and packaging to avoid issues. Finally, it is essential to understand that the importance of labeling may vary from device to device. 

11. 21 CFR Part 820 Subpart L—Handling, Storage, Distribution, and Installation 

Part 820 Subpart L of the 21 CFR specifies the handling, storage, distribution, and installation of products. This includes protocols for compliant storage and distribution. The issues that arise in this area are common because of not defining the specifications clearly. Therefore, medical device companies need to define and document all the requirements to avoid conflicts later. 

The companies need to have a quality management system to store all the documents related to internal and external specifications. Software with a centralized platform can provide your quality teams easy access to all the information required, ensuring everyone is on the same page. 

12. 21 CFR Part 820 Subpart M—Records 

Specifically, the records requirements are found in 21 CFR Part 820 Subpart M. Here; you’ll find a set of general conditions, rules for quality system records, complaint files, and the frequently misunderstood device master record and device history record. It also covers the confidentiality and retention period of the documents. 

It would be best for medical device companies to have document management software that provides scalable storage and supports all the compliance-related functionalities such as digital signature, watermark, role-based access, audit trail, and much more. The software will also allow you to define the retention period of controlled documents without any hassles. 

13. 21 CFR Part 820 Subpart N—Servicing 

The 21 CFR Subpart N is concerned with device service. It includes maintaining instructions to perform and verify servicing of the devices, analyzing service reports, identifying reports that need to be filed as a complaint, and documenting all the reports. The most common mistake companies make is not maintaining enough records to verify service. 

The medical device companies can manage services-related documents, including specifications and procedures, using the right eQMS software. It will help them to perform compliance related report submissions efficiently. Also, it will help maintain consistent flow of information in and out of the organization. 

14. 21 CFR Part 820 Subpart O—Statistical Techniques 

Part 820 Subpart O of the 21 CFR covers statistics. Accordingly, manufacturers are expected to use compliant statistical techniques to determine, confirm, and maintain the processes and characteristics that are acceptable.  

Medical device companies can look for innovative techniques to manage and maintain the statistics. The new-age tools can simplify the statistic related processes. Make sure you choose the right one for your business requirements. 

From all the requirements mentioned above, it can be estimated that medical device companies need powerful enterprise quality management software that can help them manage all the critical processes in a closed-loop system. In addition, it will create a culture of quality and continuous improvement. However, it can be a little challenging to find the right solution to cater to growing business requirements. 

But we have got you covered! 

Experience Qualityze difference in managing all the quality-related challenges of medical device companies. 

To request a free demo or get more information, please get in touch with our customer success team today at 1-877-207-8616 or write to us at, and we will be right there for you. 



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