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Steps and Tips for Streamlining Medical Devices Complaint Process


Complaint handling is an integral part of medical device companies’ Quality Management System (QMS). It involves receiving, investigating, and resolving customer complaints related to medical device products and services provided by an organization. Such complaints are related to the safety, performance, or effectiveness of medical devices, as per ISO 13485 and FDA . Companies must address complaints promptly and effectively to maintain customer satisfaction and uphold Regulatory compliance. Streamlining Medical Devices Complaint handling process is important. 

Definition of complaint from FDA in the section 21 CFR 820 and ISO 13485:2016 as below

ISO 13485:2016:

Complaints are any written, electronic, or oral communication that claims deficiencies related to the identity, quality, durability, reliability, usability, safety, or performance of a medical device or related to a service that affects the performance of such medical devices.

FDA 21 CFR Part 820:

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

Complaint files are documents that record and evaluate any complaints received from customers or users of medical devices. They are required by the FDA and other regulatory agencies to ensure the safety and effectiveness of medical devices. Complaint files help medical device manufacturers to identify and correct any problems with their products, as well as to prevent any adverse events or injuries.

What Are the different Sources of Complaints?

Customer complaints can originate from various communication sources.

Customer complaints can originate from various communication channels that a company employs to engage with its clientele. Here are examples of these sources:

  • Emails, Phone Calls: Issues reported through call centers or customer support lines.
  • Social Media: Complaints expressed on platforms such as LinkedIn, Facebook,etc
  • Live Chat: Problems communicated via website live chat features.
  • Feedback Forms: Complaints submitted through online or physical feedback forms.
  • Text Messages/SMS: Customer grievances conveyed through text or SMS.
  • Company Website: Complaints submitted through contact forms or designated portals
  • Direct Mail: Written complaints sent via postal mail.
  • Online Review Platforms: Negative reviews or complaints posted on platforms like G2 Crowd, Trustpilot, Capterra, Google Reviews, among others.
  • In-Person: Direct complaints made at physical locations of the company.

What Are Medical Device Complaint Examples?

Medical Devices examples

Here are some realistic examples of medical device complaints:

  • Device Malfunction: A pacemaker fails to function properly, causing concern for the patient’s health.
  • Software Issues: Glitches in the diagnostic imaging device software lead to inaccurate diagnostic results.
  • Product Durability: Premature breakage or wear of a prosthetic limb.
  • Adverse Reactions: Patients experience unexpected side effects, such as skin irritation from adhesive in a wearable monitor.
  • Inaccuracy: Blood glucose meter provides inaccurate readings, affecting proper management of diabetes.
  • Usability Issues: Complex controls on a portable dialysis machine make it difficult for users to operate effectively.
  • Sterility Concerns: Reports indicate that a surgical instrument pack was not adequately sterilized, posing infection risks.
  • Battery Life Problems: Short battery life in a portable oxygen concentrator leads to inconvenience and potential health risks for users.
  • Incorrect Labeling: Medical device labels contain incorrect or incomplete usage instructions, leading to misuse or confusion.
  • Delivery Delays: Critical medical devices, like ventilators, are delivered late to healthcare facilities, impacting patient care and safety.

What is the Medical Devices Complaint Handling Process?

The medical device complaint handling process is a systematic approach to receiving, evaluating, investigating, and responding to complaints regarding medical device products.  The steps involved in the medical device complaint handling process are listed below.

The following sections provide a more detailed explanation of each step, accompanied by examples of how SimplerQMS streamlines the complaint handling process.

  • Complaint Handling Process for Medical DevicesDocumenting complaints: Ensure all complaints, including oral ones, are recorded promptly, using various communication channels like phone, email, or in-person.
  • Employee responsibility: All staff should know how to handle and escalate complaints to the right department or individual.
  • Complaint documentation: Accurately document complaints on a form with customer details and a description of the issue for further investigation.
  • Initial triage: Assess complaints for validity, reportability, and potential causes such as user error or abnormal use.

 Registering a medical device complaint involves creating a formal record of the complaint and assigning it a unique number in the system, such as a customer complaint form.

include details like complaint date, description, contact info, and initial investigation. Record all complaints within 24 hours during business hours.

According to 21 CFR Part 803 and EU MDR and IVDR, for complaints that raise potential safety concerns, such as deaths and serious injuries, a medical device vigilance report must be prepared and submitted to the regulatory authorities.

  • Conduct a thorough investigation of the complaint to pinpoint its root cause. Collect all pertinent information, such as device documentation and patient details. Analyze the data meticulously to gauge severity and risks.
  • Quality assurance personnel assess if corrective and preventive actions (CAPA) are needed. This may involve design changes, process modifications, or training updates. Depending on the complaint, investigations can range from initial probes to comprehensive examinations for incidents involving harm to patients or users.
  • If no investigation is made into a complaint, the manufacturer must keep a record that includes the reason for not investigating and the name of the person who made the decision. If an investigation is made, the manufacturer must document the dates and results of the investigation, any corrective action taken, and any reply to the complainant.
  • So, now that you have conducted your investigation and taken appropriate actions, it’s time to close the complaint. Before you begin that process, you need to document parallel processes such as vigilance reporting, risk management file updates, and CAPA, if applicable. If you ended your investigation after Level I, you need to document in your complaint files that further investigation was not required and why. It’s important that you codify the closeout type so you can use this for trending.
  • If the complaint proceeded to Level II but ended there, you will again need to document why a root cause analysis was determined to be unnecessary. Include all data and reports, as well as a summary statement for the complaint file.
  • Finally, if the complaint proceeds all the way to Level III and you end up preparing a CAPA, your system may allow you to close the complaint by referencing the ongoing work in the CAPA. This is useful, as you may have additional complaints for the issue before your corrections and corrective actions are implemented.
  • Throughout the investigation, parallel processes like vigilance reporting and updating risk management files should be documented. If the investigation concludes early, reasons for ending it must be recorded. Similarly, if it progresses to preparing a CAPA, the complaint may be closed with reference to ongoing CAPA work to address the issue comprehensively, especially considering potential further complaints on the same matter before CAPA completion.
Overview of complaint handling process ( image credit 4 easyreg )

What are the Regulatory Requirements for Medical Devices Complaint Handling?

Complaint handling is an integral part of medical device companies’ Quality Management System (QMS). It involves receiving, investigating, and resolving customer complaints related to medical device products and services provided by an organization. Such complaints are related to the safety, performance, or effectiveness of medical devices, as per ISO 13485 and FDA . Companies must address complaints promptly and effectively to maintain customer satisfaction and uphold Regulatory compliance.
Regulatory requirements plays vital role to maintain the control over product quality, patient safety.
ISO 13485:2016
  • The  ISO 13485:2016 standard,Section 8.2.2 of the standard mandates that medical device companies establish and document procedures to handle complaints promptly and in accordance with relevant regulatory requirements.
  • This encompasses the tasks of receiving and documenting complaints, evaluating whether feedback meets the criteria for a complaint, conducting thorough investigations into complaints, determining the necessity of notifying regulatory bodies, managing products associated with complaints, and deliberating on the need for corrective measures.
21 CFR 820
  • The 21 CFR Part 820 is a regulation issued by the United States Food and Drug Administration (FDA).
  • 21 CFR 820.198 provides the details of complaint handling. The requirements are related to your general recordkeeping requirements that are laid out in 21 CFR 820.180. Note that the regulatory requirements of complaint-handling extend to other areas of regulation. For instance, 21 CFR 803, MDR reporting requires that major device problems have to be reported with MedWatch Form 3500.
21 CFR Part 803
  • Medical device manufacturers, importers, and device user facilities are given separate guidelines for medical device reporting under 21 CFR 803
  • The purpose of the regulation is to ensure that the FDA is aware of any serious injuries or deaths associated with medical devices.
  • As Per regulation 21 CFR 803.18(d), device companies must maintain procedures for recording complaints. Required patient info includes name/ID, age at event, DOB, gender, weight. Medical history covers conditions, allergies, meds. Event description must be detailed. Note outcomes (e.g., death, injury). Provide test/lab data dates/results. Include device details: name, model, lot/serial numbers. Manufacturer info: name, address, contact.
  • The European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) set standards for safety, performance, and quality of medical devices and in vitro diagnostic medical devices. Article 87 mandates manufacturers to submit vigilance reports, documenting incidents and corrective actions. Incidents resulting in death, serious injury, or patient health deterioration must be reported.
  • Post-market surveillance (PMS) includes collecting and evaluating data like serious incidents, safety actions, non-serious incidents, side effects, trend reports, and literature reviews. Users, distributors, and importers contribute complaints and feedback, along with publicly available data and periodic safety reports.

Need help with Complaint Handling Process

What type of information need be mentioned in a complaint received from a customer?

Before we get into the issue of whether a complaint is reportable, let’s talk about what information needs to be captured when a new complaint is received. There is specific information that, at a minimum, you must collect. This includes:

  • The date of the event, which can be different from the event was reported to the manufacturer.
  • The place when the event occurred.
  • Contact information for the complainant
  • A description of the event, thus what exactly happened, or a description of the failure or potential failure, etc
  • The medical device involved, including all the information needed to properly identify (UDI)
  • Any information related to the involvement of the patient in the specific event and, in case, the consequences of the event on patient, user or any other person involved. If there were consequences, it is often necessary to know whether there was medical intervention on the patient and/or in general the so-called patient outcome.
  • Need for further investigation and record of investigation (if needed)
  • Any corrective action taken

Sometimes, this information is not available and it is necessary to contact the customer to collet all the necessary pieces of information.

Communicating the outcome of Complaint investigation

Establishing a robust process for internal and external communication is crucial for effectively addressing issues and preventing their recurrence. Internally, incorporating complaint information into design and manufacturing processes is vital. Mechanisms such as CAPA (Corrective and Preventive Action) and statistical monitoring help track complaints and their resolutions.

Externally, providing feedback to customers and regulators through vigilance reporting and recall communications ensures transparency and accountability. Sharing investigation findings and corrective actions is essential for improving product quality and safety.

Once you have organized your team and established a framework for gathering PMS data, you need to translate data into information. This is where complaints, PMS, and risk management intersect. Evaluate the information using sound statistical rationale and objective risk-based decision making.

Finally, you need to have a process established so that you properly communicate the issues to the appropriate people within the company. Complaints and PMS are important inputs to management review, and outcomes of this review include resources and actions. After all, investigating the root cause of a failure is time wasted if that knowledge is not shared with the people who can prevent it from happening again.

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Sagar Pawar

Sagar Pawar

Computer System Validation Specialist