Post-Compliance Medical Device Regulations and Evolving Reporting Requirements: Complaint Handling, Medical Device Reporting/ eMDR and Recalls and their compliance with UDI's

Post-Compliance Medical Device Regulations and Evolving Reporting Requirements: The FDA keeps on enhancing its devices and systems in its command to secure the general well being. Post-showcase exercises, including electronic revealing, UDI (Unique Device Identifier) prerequisites and Emerging Signals Guidance are all part of the development in desires for Quality Systems for Medical Device organizations. Execution of necessities for electronic therapeutic gadget detailing was critical to lessening workload, enhancing examination, and expanding speed in identifying and revealing issues. UDI (Unique Device Identifier) gives away to all the more effortlessly and precisely distinguishing, breaking down, and drifting items and quality issues. What's more, draft direction on "Rising Signals" is the following stride in offering quality worries to the general population to forestall potential damage. These progressions mirror the advancement in intuition and quality framework desires for medicinal gadgets. Medicinal gadget organizations need to comprehend the changing administrative atmosphere and set up their procedure for what's to come. This online class will help you comprehend the effect of the progressions and help you plan.

Complaint Handling and Medical Device Reporting are viewed as critical procedures by the FDA in keeping up the general population well-being. Since they are so critical they were as often as possible reviewed regions by the FDA. All the more essentially, protestations can likewise be an early cautioning of issues with your items and client issues. It is imperative to have proficient and powerful procedures for overseeing, breaking down, drifting, and detailing item issues. Disappointment examinations and CAPA are essential to comprehension and settling these quality issues. What's more, redresses and expulsions are once in a while essential. This online class will cover the fundamentals of these vital quality framework necessities.

This preparation program will talk about the rudiments of the Medical Device Complaint Handling Regulations and audit the procedure for getting ready to satisfactorily set up and keep up the methodology for getting, checking on, and assessing protests. It clarifies a legitimate treatment of objections. What is reportable or non-reportable to the FDA for an item protestation, taking care of and documentation, how and when to record Medical Device Reports (MDR), and enter calculates actualizing and keeping up consistency under 21 CFR 803 directions and genuine encounters of the FDA.

Areas Covered in the Seminar

• Complaint Handling and FDA Expectations
• Medical Device Reporting Procedures (
• MDR)
• MDR FDA Perspective
• User Error Malfunction
• Recalls: Definitions and Legal Authority
• Being Recall Ready -Proactive Steps to Avoid Crisis
• Evaluating Risk and Health Hazard Evaluation (HHE)
• Corrective and Preventive Action System
• Elements of Correction and Removal Report
• Developing effective Strategies and Communicating with FDA
• Notification Letters and Press Releases
• Silent Recalls vs. Product Enhancements and Enforcement by FDA
• Product Retrieval Issues, Effectiveness Checks and Status Reports
• Termination of a Recall

REGISTER for the Seminar Post-Compliance Medical Device Regulations and Evolving Reporting Requirements: Complaint Handling, Medical Device Reporting/ eMDR and Recalls and their compliance with UDI's

Quality Management Systems that Comply with ISO13485:2016

Course Description:

The Course "Quality Management Systems that Comply with ISO13485:2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

ISO 13485:2016 indicates prerequisites for a quality administration framework where an association needs to exhibit its capacity to give medical devices and related administrations that reliably meet client and relevant administrative necessities. Such associations can be included in at least one phase of the life-cycle, including plan and advancement, creation, stockpiling and circulation, establishment, or overhauling of a restorative device and outline and improvement or arrangement of related exercises (e.g. specialized support).

Prerequisites of ISO 13485:2016 are relevant to associations paying little heed to their size and paying little mind to their sort with the exception of where expressly expressed. Wherever prerequisites are indicated as applying to restorative devices, the necessities apply similarly to related administrations as provided by the association. 

The procedures required by ISO 13485:2016 that are pertinent to the association, yet are not performed by the association, are the obligation of the association and are represented in the association's quality administration framework by checking, keeping up and controlling the procedures. 

On the off chance that appropriate administrative necessities allow prohibitions of plan and improvement controls, this can be utilized as a defense for their avoidance from the quality administration framework. These administrative prerequisites can give elective methodologies that are to be tended to in the quality administration framework. It is the obligation of the association to guarantee that cases of adjustment to ISO 13485:2016 mirror any rejection of plan and improvement controls.

For a long time, ahead of schedule in the life of ISO 9001 and ISO 13485, it took a ton of instruction with respect to ISO examiners to show organizations the contrast between Corrections (settling the issue) and Corrective Actions, fixing the underlying driver of the issue. Organizations have now taken in these definitions truly well. In any case, the Corrective Action and Preventive Action (CAPA) framework frequently do not cover rectification and control activities identified with CAPAs. Adjustments for item issues are generally being done under different bits of ISO 13485, for example, control of nonconforming item and client criticism and grievances. These regularly have the little visibility in the Corrective Action framework, and by and large, don't address at all containing or rectifying quality framework issues that are frequently a noteworthy part of a CAPA framework. So now ISO evaluators, or if nothing else ISO 13485 Notified Body reviewers, are expecting that organizations record and give prove that they are doing regulation as well as rectifications, totally and rapidly. 

Join Lena Cordie  in this interactive workshop to get detailed guidance on how to develop, implement and maintain strategies in order to achieve a specific goal. This session will include lectures, round table discussions and activities all aimed at understanding key strategies and identifying specific actions to effectively improve Quality Management System Compliance.