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Medical Device Complaint Handling Processes

If you are a medical device company, you will understand the need to comply with both international and regional regulatory rules and regulations.

A very important regulatory quality standard that is enforced by the US FDA (21 CFR Part 820.198) in the North American market and by regulatory authorities in the European Union (ISO 13485:2016, section 8.2.2) is the Customer Complaint Handling Process.

This will be part of your Medical Device Quality Management System.

Let us say that your company manufactures implantable pacemaker pulse-generators, Class III medical devices that have a high risk for the end-users. You start receiving complaints from cardiologists that several of these devices are malfunctioning – a potentially serious problem.

You will need to maintain a complaints file that will contain all relevant details of the complaint. Then, investigate the complaint within a suitable time frame and, if required, report the same to the regulatory agencies. Hence, medical device complaint handling is not only a regulatory requirement but also shows the importance that your company gives to the handling of complaints, whether minor or major problems.

This article provides answers to many of the common questions that you may have regarding medical device complaint handling, and demonstrate the role of using a digital solution for managing complaints.

We will take a more in-depth look at the following topics:

Definition of a Complaint

The FDA 21 CFR Part 820.3 defines a complaint as the following:

“any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.”

Similarly, ISO 13485:2016 defines a complaint as:

“written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization’s control or related to a service that affects the performance of such medical devices.”

We see from the above definitions that complaints can be oral, electronic, or written statements from customers that contend that one or more of your medical device products in the market have deficiencies concerning their identity, quality, robustness, safety, efficacy, or performance.

Examples of medical device complaints:

  • Labeling error resulting in 3 cc syringes labeled as 5 cc syringes
  • Malfunctioning electric wheelchairs
  • Mobility assistive equipment such as walkers and crutches break under the slightest pressure
  • Cardiopulmonary bypass devices breaking down
  • Inadequately designed incubators

As you can see, medical device complaints can be of a very broad nature.

Furthermore, it can become difficult for your company to handle these complaints if you are still using the traditional paper-based manual systems of documenting and follow-up of complaints.

With the use of a medical device eQMS software such as SimplerQMS, you will see that it goes together with your complaint handling system by allowing your company to effectively manage complaints of any product throughout its lifecycle. This takes into account all documentation, complaint investigations, root-cause analysis, CAPAs, regulatory reports and submissions, device history records, and much more.

What is the Difference Between Complaints and Feedback?

A complaint alleges that there are deficiencies concerning your product in the market. These deficiencies could be related to the effectiveness, quality, safety, or reliability of the product. This indicates that complaints are negative.

Management of a complaint is both a regulatory and business necessity.

On the other hand, feedback can be either positive or negative. This means that not all feedbacks are complaints.

Let us take a look at some examples to understand this better.

Examples of feedback:

  • Appreciation for a new product in the market when compared to similar existing products
  • Errors in shipping your product from warehouse to customer
  • Cosmetic defects in a product
  • Inquiries regarding product information

Examples of complaints:

  • Product not functioning according to specifications
  • Product causing serious harm due to malfunctioning parts
  • Product wrongly labeled

Sources of Medical Device Customer Complaints

Your medical device company can get complaints from different sources via different methods, for example:

  • Walk-in customers
  • Telephonic grievances
  • Online forms
  • Via your company’s email ID
  • Online product reviews
  • On social media

Some customers may even send letters to your company’s post-box (the old-fashioned way!)

Medical device Complaints Classification

Complaints about your medical devices that are on the market can be grouped into two categories:

  • Incident-driven complaints
  • Review-driven complaints
Post-Market Issue Classification

Incident-Driven Complaints

A malfunctioning electric wheelchair that caused serious harm or death to a patient or a complaint from a hospital that your cardiopulmonary bypass device malfunctioned during a critical surgery are examples of incident-driven complaints.

Such complaints will require urgent attention from your company.

Review-Driven Complaints

Review-driven complaints are based on postmarket surveillance, i.e., a review of data.

For example, while reviewing the performance records of portable incubators, you noticed recurring breakdowns under specific situations. This is a problem related to the functioning of the device and needs to be investigated.

With the SimplerQMS software, you will be able to effectively categorize the different types of complaints pertaining to one or more of your products. This way you will be able to manage customer complaints more efficiently.

What is Medical Device Complaint Handling Process?

Complaint handling in the medical device industry is a regulatory obligation and a critical risk-reduction tool.

When your medical device company receives a complaint about a product in the market, you will need to rigorously document and evaluate the same using your company’s customer complaint handling process.

After you review the complaint, you will need to determine whether a formal complaint investigation in the form of corrective and preventive action (CAPA) is required. If a CAPA is not necessary, then document the reason.

Benefits of a Well-Designed Complaint Handling Process

Complaints can come from the most unexpected of places.

Even with all processes and protocols in place, it is almost impossible to eliminate complaints. So, the next best thing that you should invest in is a well-designed complaint handling process.

The benefits of such a well-designed complaint handling process are many.

To name some:

  • Regulatory compliance: The most obvious considering that US FDA 21 CFR Part 820.198 and ISO 13485:2016 8.2.2 mandate them.
  • Maintaining brand value: When your company handles complaints efficiently via a well-designed complaint handling process, your customers will be most appreciative. The positive feedback that you receive will enhance the brand value of your company. You will build a long-term relationship with such customers.
  • Monitoring quality of products: You will get the correct feedback on your products. This will help your company monitor the quality of the products in the market, and, give valuable inputs for the development of more efficient products.
  • Reduction in cost of labor: You will get valuable inputs with which you are able to develop safer, better products. This will reduce your labor costs going forward.

What Are Customer Complaint Handling Requirements?

Regulatory requirements regarding medical device customer complaint handling are as follows.

US FDA 21 CFR Part 820.198 (a) states that:

“Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.”

ISO 13485:2016, in section 8.2.2, about complaint handling, states that:

The organization shall document procedures for timely complaint handling in accordance with applicable regulatory requirements. These procedures shall include at minimum requirements and responsibilities for…’

Furthermore, US FDA 21 CFR Part 803 states that:

“(a) This part establishes the requirements for medical device reporting for device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports.“

21 CFR Part 820.198 and ISO 13485:2016 (section 8.2.2) emphasize that your medical device company must have complaint procedures for properly receiving, reviewing, and evaluating all complaints. All complaints are to be processed promptly, and in the case of the US market, you will report these complaints to the FDA as per 21 CFR Part 803.

Whether it is a customer orally complaining or a complaint is received via email, social media, etc., medical device companies should have proper protocols and procedures in place to receive, record, and review all such complaints.

What is crucial to the medical devices industry is the effective handling of such complaints and reporting them to the regulatory authorities promptly. Standardized complaints handling process will turn customers’ complaints into product improvement strategies. This will further increase the satisfaction of your customers.

With SimplerQMS software, you have an all-in-one quality management software solution with a built-in complaints management module. It complies with post-market regulatory requirements and will help you identify, analyze and resolve your customers’ complaints efficiently and in compliance with ISO and FDA requirements.

What Are the Steps in Handling Complaints?

As mentioned earlier, medical device manufacturers are required under regulatory rules to establish a customer complaint handling process.

A representative medical device customer complaint handling flowchart is illustrated below.

Medical Device Complaint Handling Process Flowchart

The different phases in this process are described in more detail below.

Phase 1: Customer Complaint

Your company may receive a complaint via oral, written, or electronic means.

As an example, a hospital may send an email to you stating that the cardiopulmonary bypass devices that you have installed in their institution have started malfunctioning.

Phase 2: Registration of Complaint

A dedicated customer service representative/department in your company will document the details and assign a complaint tracking number.

Looking at the example of the malfunctioning cardiopulmonary bypass devices, your customer service department will document details such as the batch number, model, year of manufacture, etc, and raise a complaint tracking number.

With the SimplerQMS customer complaint management software module, you get ready-to-fill complaint forms that make it easy to capture the complaint with all the necessary data points.

Phase 3: Medical Review Report (MDR) submission

Is the complaint a reportable event?

Looking at the previous example, the complaint about the malfunctioning cardiopulmonary bypass devices is a reportable event.

FDA 21 CFR 803 Medical Device Reporting (MDR) regulations and ISO 13485:2016 8.2.3 lay out the requirements for regulatory reporting.

Your company must report all such incidents as soon as you are aware of the fact that your device has malfunctioned to such an extent as to cause serious injury/death or has contributed to a serious injury/death.

Using SimplerQMS, you have the option of reporting such an incident. This is dependent on whether or not there was an injury/death or risk of injury/death with your product.

Medical Device Reporting (MDR) Using SimplerQMS

Phase 4: Investigative Phase

In this phase of the complaint handling process, you need to determine the origins and magnitude of the issue.

For example, were the malfunctioning cardiopulmonary bypass devices from only a single medical center or multiple medical facilities?

You will also need to understand whether this issue is connected to other similar products, processes, etc. Therefore in the investigative phase, you will determine whether a CAPA is required or not.

Note that the complaint handling process and CAPA or two different processes that need to be documented independently.

If a complaint does not require a CAPA, you need to document the same and give the reasons for doing so.

You will realize that both the complaint handling process and CAPA processes need to be documented and investigated as part of your company’s QMS. With the help of the SimplerQMS CAPA software solution, you will easily and efficiently identify, uncover, resolve, and seamlessly report all CAPAs.

Recommended Reading: What Is CAPA in the Medical Device Industry?

Phase 5: Complaint Closure

Your company has taken all the necessary actions concerning a customer’s complaint.

You are now ready to close the complaint and determine the effectiveness of the remedies taken. This becomes particularly true if you do not receive similar complaints in the future.

Irrespective of the phase at which the complaint was closed, you need to document the parallel processes that you are taking, such as filing CAPA (if necessary), vigilance reporting, and updating risk management files.

With SimplerQMS, you can manage all your customer complaints in a single place. The software enables you to document the necessary information, such as product information, customer details, complaint description, root cause analysis, and corrective/preventive actions taken.

Easily overview the trending of open and closed complaints with the help of automated KPI reports, and track the status of documentation and the assignment of each user through customizable dashboards.

Customer Complaint Dashboard View Inside SimplerQMS

Best Practices for Medical Devices Complaints Handling

The best practices that your company can implement concerning handling complaints from customers regarding your products are as follows.

Adopt a Robust Complaint Handling Protocol

The very first step you need to take is to implement a robust complaint handling protocol and commit resources and personnel to it.

You should remember that it is a mandatory requirement as part of your medical device QMS.

An efficient QMS software solution with built-in complaint handling software like SimplerQMS can automate your complaint handling process, make it more streamlined and help ensure compliance with regulatory requirements.

Provide Resources  in the Form of Personnel, Training, Documentation, and an eQMS

Knowing that the medical device customer complaint process is a mandatory requirement, you will need to provide adequate resources in the form of personnel, their training, documentation, and other requirements.

When your personnel is properly trained, they will acquire such skills as given below:

  • Ability to distinguish and identify between customers’ feedback and complaints
  • Ability to classify complaints into incident-driven and review-driven complaints
  • Ability to evaluate whether a complaint warrants reporting to regulatory bodies
  • Ability to conduct a detailed investigation following standard protocols
  • Close complaints effectively and promptly in the given time frame

Let us look at some examples in this regard:

  • Your company has received an email from a hospital client that because of an error in shipping from your side, the product ended up in a sister concern in the same city. Your team will realize that this is negative feedback and, therefore, a complaint should not be filed.
  • Your company has received a customer’s complaint via a letter posted to your head office. When your employees are properly and efficiently trained, they will understand that complaints can come in many different ways, including in the form of posted letters. They will scrutinize the complaint and take the necessary actions.
  • The staff has reviewed the service records of the BP monitoring devices. And noticed that these devices are malfunctioning under certain conditions. When the employees are trained well, they will appreciate that this is a review-driven complaint, since the reliability of the device is at stake here.
  • In the example of the malfunctioning cardiopulmonary bypass devices mentioned earlier, your complaints department will if properly trained, understand the gravity of the situation. The relevant personnel will investigate the problem and close the complaint promptly and effectively, within a given time frame.

You will understand that all this requires an enormous amount of detailed documentation.

With, you are assured of the completeness of all data, especially when you use best-practice forms and pre-configured workflows, which also help you ensure everything you do is streamlined and legally compliant.

Localize Your Complaint Management Group

Rather than centralizing complaints that may arise in different countries, a global medical devices company can localize its complaint management groups.

This way, you will avoid problems related to translating complaints from one language to another, and the need to have one or more translators in-house.

Pay Attention to Details

It is critical that your investigations into customers’ complaints are methodical and properly documented.

The amount of details that must be documented should be appropriate to the complexity of the device in question.

Recommended Reading: Medical Device Document Control: What It Is & How to Simplify It

Adhere To Strict Timelines

Your investigation into complaints must adhere to strict deadlines.

Ensure that the concerned personnel understands the gravity of such complaints and that they efficiently complete the investigations and close the complaints promptly.

SimplerQMS helps you ensure that your medical device company always meets deadlines and closes complaints in a timely manner. With features like automated workflows, email notifications, reminders, and customizable dashboards, you can track every aspect of the process and make sure nothing falls through the cracks. If anything does come up, you can easily escalate it to the appropriate manager.

Medical Device Complaint Handling Software

Traditional paper-based quality systems are not only obsolete but also have many disadvantages.

To name a few:

  • Security issues because documents can get damaged, mishandled, lost, or stolen
  • Transportation of documents is both slow and inefficient
  • Issues with editing and correcting paper-based documents
  • A huge disadvantage is the associated costs both to your company (in the form of tons of stationery, printers, and photocopiers) and the environment

Avoid these problems by investing in a medical device QMS software such as SimplerQMS and eliminate all the problems rising from paper-based systems.

Your organization will securely and easily manage the entire complaint handling process anywhere in the world through our customer complaint management solution.

Not only will you work efficiently with your complete documentation, but you also maintain compliance with international regulatory requirements of the FDA, ISO 13485, QSR, and others that are pertinent to life science organizations.

The medical device complaint handling software solution that is built into the SimplerQMS suite makes it easy and efficient for your medical devices company to manage customers’ complaints, document complaint reviews, and investigations, and share applicable information with personnel and the regulatory agencies.

Additionally, the SimplerQMS software system provides an overview of medical device complaints trending over various periods.

SimplerQMS Complaint Management Software Interface

Final Thoughts

Your medical devices company must have an effective customer complaint handling process in place.

It is not only a regulatory requirement in the US and Europe but will also highlight your company’s concern for the end-users.

The customer complaint handling process can become cumbersome and difficult with a paper-based QMS. You can streamline the entire process following regulatory requirements when you invest in QMS software with customer complaint management capabilities.

If you are interested in streamlining your complaint handling process and want to see for yourself how SimplerQMS can make you more efficient, book a personalized demo today and talk to the experts.

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