Complaints very strongly show a company how its products or services are perceived where it matters the most -in the customer’s mind. Complaint handling is one of the key indicators of how seriously a business takes its customers’ point of view. Complaints are to be expected from about any product; but their importance is all the more felt in an area like medical devices, because these products can affect the very life of their users.
In the context of medical devices; complaints are any communication made in writing, electronically or in verbal form about any of these aspects of a medical device after its release for the purpose of distribution: identity, quality, durability, reliability, safety, effectiveness, or performance
FDA and ISO standards
The FDA has a very clear and well-defined set of regulatory guidelines on complaint handling in the field of medical devices. These are set out in FDA 21 CFR 820.198. The FDA requires medical device companies to also comply with ISO 13485:2016 Section 8.2.2., which suggests what document procedures to put in place to ensure timely handling of complaints in a compliant manner. Just how seriously the FDA takes complaint handling can be gauged from the fact that deficiency in complaint handling is one of the top reasons quoted for issuance of 483’s by the FDA.
Although complying with these regulations is a part of regulatory requirements; these regulations only mention what needs to be done in order to maintain a complaint and recall management system; how to do it is left to the individual medical device company. These regulations specify the exact elements of a complaint handling system, such as maintaining complaint files, proceeding about the complaints in a timely manner, documenting verbal complaints, and so on. However, it is up to the medical device manufacturer to implement the complaint handling and recall system in such a manner that it is perfectly streamlined and organized to the point where the complaint is handled exactly in the manner prescribed.
Full learning on how to implement an effective and compliant complaint and recall management system
The ways by which medical device companies can do this to optimize their complaint handling mechanism will be the teaching from a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing. At this seminar, John Kasoff, Director of Regulatory Affairs, Life-Tech, Inc. and Principal Consultant at Lean to Quality, LLC, who brings more than three decades of experience in Quality and Regulatory management, during which he has implemented and overseen quality system operations and assured compliance, at all companies of all sizes, from start-up to more than $100 million in revenue; will be the Director.
Please visit Putting an effective complaint and recall management system in place to enroll for this seminar and gain thorough understanding of how to put an effective complaint and recall management system in place. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
An activity that cuts across many cross functions
Jeff will emphasize the point that complaint handling is a highly coordinated, cross functional area for a medical device company’s Quality System. Almost all niche areas of the medical device company, such as customer service, sales and marketing, Regulatory Affairs, QA, R and D, and Quality Engineering, are involved in complaint handling. This makes the need for orchestrated coordination and synchrony between these departments a must, for if the complaint handling mechanism is not well lubricated; it is bound to make the complaint handling act a failure, inviting all the undesirable penal actions from the regulatory and enforcement agencies.
John will highlight the role and importance of each of these functions in complaint handling. In these, activities relating to defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications, will be discussed in detail.
Distinguishing between complaints and “non-complaints”
He will also explain what constitutes a complaint, and will suggest recommended practice on the ways of handling “non-complaint” feedback. He will also show how to apply risk management to a complaint handling system, and explain a specific risk management system to drive home this point.
A substantial part of this seminar will be spent on making a streamlined review of the regulations, at which the critical process requirements for compliance with the regulations will be examined in detail. Jeff will offer straightforward and compliant recommendations for the methods of documentation relating to complaint records, root cause investigations, and corrective actions, and show how to apply risk management principles to complaint investigation.
To join us for more information, get in touch