Antrix, Inc ANTRIX, Inc
Regulatory Affairs & Quality Assurance Consulting Services for
Medical Device and Medicinal Drugs
O 408 733 1199
F 408 730 5959
 info@antrix.com

Complaint Handling, Recalls and Medical Device Reporting

1. Service Description

We provide customized service and help in implementing  a complaint systems for manufacturers to monitor customer satisfaction that provide key input to their CAPA systems.  ISO/FDA’s inspection strategy have reinforced the importance of robust complaint investigations and record keeping.

There will be productivity increase and cost savings of more than 70% using our service. Your company will save money from several thousand to millions of dollars adding to your bottom line profit.

We can setup a system for Quality Assurance to routinely monitor service work orders, product replacement requests and complaints, to ensure that there is no evidence of a chronic or inherent product problem. If there is evidence that suggests a a problem, QA will escalates it to the appropriate group (Manufacturing, Product Sustaining Team, etc.) for further investigation. Once the investigation is complete, QA will works with a corrective action team to ensure that the appropriate actions are taken to correct the problem and prevent it from recurring.


2. Cost Savings - Return on Investments (ROI)

Amount of money saved by your company on using our service based on the company size is provided in the Table 1.0.

Projected savings is based on

  1. Process efficiency gains (people)
  2. Less personnel requirements (people)
  3. Infrastructure efficiency gains (systems)
  4. Infrastructure validation and maintenance (systems)
  5. Delivering quality products
  6. Avoid regulatory noncompliance cost
  7. Avoid regulatory fines cost

Compared to cost associated with company's inefficient internal manual methods, , systems, tools, software’s, and personnel etc. Detailed Return on Investment (ROI) information is available on request.

Company Size Small Medium Large
$Savings > 70 % > 70 % > 70 %
Annual Sales < $100 million $100 million < Sales < $500 million > $500 million
Number of Submissions <= 2 per year 2 < Sub <= 4 per year > 4 per year

Table 1.0 - Amount of money saved by your company on using our service. Company size is based on annual sales as per FDA classification.


3. Solution Approach

  1. We review the requirements for complaint handling from the Quality System Regulation (QSR) and Medical Device Directive (MDD)
  2. Identify the appropriate sources for complaint information
  3. Write a Complaint Handling and Investigation Procedure, and develop Complaint Handling Forms
  4. Describe steps for a careful and complete investigation, and outline the records that must be kept
  5. Identify Medical Device Reporting and Vigilance decision process, and also the requirements and steps for field actions (advisory notices, recalls, etc)
  6. In case of recall document field correction or removal with level of detail expected by the FDA to complete the activity in timely and efficient manner
  7. Strategy to decide if a recall is necessary, how to interact with the recall coordinator at the FDA district office, what the FDA expectation will be, how to follow up to insure the recall is effective and finally, how to close the recall activity
  8. In addition to strategy on the domestic recall requirements,  we also cover what must be done if products are also sold internationally

Example Complaint Management Process Comprised of Five Key 
SubProcess Which Cut Across Different Functions

Figure 1 - Example Complaint Management Process Comprised of Five Key SubProcess Which Cut Across Different Functions - Source Deloitte


4. Definitions

Complaint: Complaint means 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.

MDR: Medical Device Report

MDR reportable event (or reportable event) means:

(1) An event that user facilities become aware of that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or

(2) An event that manufacturers or importers become aware of that reasonably suggests that one of their marketed devices:

(i) May have caused or contributed to a death or serious injury, or

(ii) Has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Correction means the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location.

Correction or removal report number means the number that uniquely identifies each report submitted.

Market withdrawal means a correction or removal of a distributed device that involves a minor violation of the act that would not be subject to legal action by FDA or that involves no violation of the act, e.g., normal stock rotation practices.

Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death.

Removal means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection


5. Applicable Laws, Regulations and Standards

  1. Title 21 CFR Part 820.3 (b) - FDA’s Complaint Definition
  2. Title 21 CFR Part 803 – Medical Device Reporting
  3. Title 21 CFR Part 806 – Reports of Corrections & Removals
  4. Title 21 CFR Part 810 - Medical Device Recall Authority
  5. Title 21 CFR 820.198 - Complaint Files