Placing an effective grievance and recall system

Placing an effective grievance and recall system

Complaints greatly show the company how its product or service is considered most important – in the minds of customers. Complaint handling is one of the main indicators of how serious a business takes its customer standpoint. Complaints should be expected from any product; However, their interests are increasingly felt in areas such as medical equipment, because these products can affect the lives of their users. In the context of medical devices; Complaints are communications made in writing, electronically or in verbal form concerning the following aspects of medical devices after being launched for distribution purposes: identity, quality, durability, reliability, security, effectiveness, or FDA and ISO performance standards. The FDA has a very clear and well-defined set of complaint handling guidelines in the medical device field. These are listed in the 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 should be prepared to ensure timely handling of complaints in an appropriate manner. How serious FDA complaint handling can be measured by the fact that lack of complaint handling is one of the main reasons for issuing 483 by the FDA. Although complying with this rule is part of the regulatory requirements; this regulation only mentions what needs to be done to maintain complaints and recall Placing an effective grievance and recall system¬† systems; how to do it submitted to an individual medical device company. This rule specifies the exact elements of the complaint handling system, such as maintaining a complaint file, continuing complaints at the right time, documenting oral complaints, and so on. However, it is up to the manufacturer of the medical device to implement a complaints handling and suspension system in such a way that it is highly efficient and organized to the point where complaints are handled appropriately as prescribed. Full learning on how to implement an effective and appropriate complaints management system and recall The way medical companies can do this to optimize their complaint handling mechanism will be the teaching of a two-day seminar that GlobalCompliancePanel, a leading professional training provider for all regulatory compliance areas, is set up. At this seminar, John Kasoff, Director of Regulatory Affairs, Life-Tech, Inc. and Principal Consultant at Lean to Quality, LLC, which has more than three decades of experience in Quality and Regulatory management, where it has implemented and overseen the quality of system operations and compliance assured, in all companies of all sizes, from initial revenue to more of $ 100 million; will become Director. Please¬† to attend this seminar and gain a thorough understanding of how to apply effective complaint and reminder systems. The seminar was approved by RAPS eligible for 12 credits against RAC recertification after completion. Activities that cross many of Jeff’s functions will emphasize that complaint handling is a highly coordinated cross-functional area for the Medical Device Quality System. Almost all of the niche areas of medical device companies, 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 coordination and synchronization arranged between these departments to be done, because if the complaint handling mechanisms are not well lubricated; This undoubtedly makes the complaint handling fail, inviting all unwanted criminal actions from regulatory and enforcement agencies. John will highlight the role and importance of each function in handling complaints. In this case, activities related to defining, documenting and implementing complaints handling systems, requirements for complaint review, investigation and corrective actions, and specific implications of ISO, will be discussed in detail. Differentiate between complaints and “no objections” He will also explain what constitutes complaints, and will suggest suggested practices on how to handle “non-complaint” feedback. He will also show how to apply risk management to the complaint handling system, and describes a specific risk management system to take home at this point. An important part of the seminar will be used to make a review of the simplified rules, in which the criteria process requirements Placing an effective grievance and recall system