Medical Device Reporting

FDA Issues Warning Letter to Battelle Memorial Institute, a Manufacturer of an Authorized Decontamination System Used on Respirators | BioSpace | 10/7/2020

SILVER SPRING, Md. , Oct. 7, 2020 /PRNewswire/ – Today, the U.S. Food and Drug Administration (FDA) issued a warning letter to Battelle Memorial Institute for failure to comply with regulatory requirements for medical device reporting as specified in the Emergency Use Authorization (EUA) for the Battelle Critical Care Decontamination System. “It is critical that manufacturers have an effective process in place for reporting adverse events related to the use of authorized …

FDA explains how EUA medical devices can electronically comply with AE reporting requirements | 9/12/2020

… policy guidance document issued in response to the COVID-19 pandemic specifies the AE reporting requirements for manufacturers, and often user facilities, of the device(s) it covers. These requirements typically follow the standard medical device reporting (MDR) requirements established in 21 CFR Part 803, including the criteria for when an AE or malfunction is reportable and the timelines for reporting. Accordingly, this updated policy represents a significant change for …

FDAnews Announces —17th Annual Medical Device Quality vCongress, Wednesday, Oct. 7 – Thursday, Oct. 8, 2020 | PRWeb | 9/4/2020

… EU-IVDR) — what one must know to obtain a CE Mark QMS under EU-MDR and EU-IVDR — create a foolproof QMS Complaint reporting — save time and money by avoiding resubmission requests with U.S. medical device reporting (MDR) and EU-MDR’s/IVDR’s new manufacturer’s incident report (MIR) Corrective actions — U.S. and EU perspectives, including EU-MDR/IVDR field safety corrective actions (FSCAs), field safety notice (FSN) and other reports one …

Complaint Systems Investigator – CONMED – Largo, FL | 7/16/2020

CONMED offers more than 10,000 medical devices to healthcare providers around the world. As a complaints investigator for CONMED, you will review, investigate and process domestic and international complaints for Medical Device Reporting (MDR) and International (Vigilance) Device reporting requirements based on FDA Regulations, and International [Medical Device Directive (MDD)] Device Reporting requirements. You will be a vital part of leveraging customer feedback for improving the design of current and …

How to get ISO 13485 certified, time for success? | 6/16/2020

… 1) design controls, 2) risk management, 3) software development (if applicable), and 4) usability. Therefore, these represent the seven procedures that most companies will implement as early as possible. Procedures such as complaint handling, medical device reporting , and advisory notice procedures are usually reserved for last. These procedures are last because they are not needed until you actually have a medical device in use. Task 5 – Create forms, flowcharts, and …

Secant Medical Inc. | 6/11/2020

As imaging gets more high tech, so too must the solutions that enable more convenient viewability of it. Sean Fenske, Editor 02.24.17 The Benefits of Electronic Medical Device Reporting Most tend to think of safety and quality in two separate spheres. In truth, these two are closely linked—having a total safety mindset often means having a quality mindset. Someone consistently acting in a high-risk manner will likely create …

CDRH Reorganization Takes a Total Product Lifecycle Approach; MDSAP, ISO Adoption, and Collaboration with MDIC Moving Forward | 4/2/2020

… the Total Product Lifecycle (TPLC) Office,” having created its first one in 2002 around a specific product―the Office of In Vitro Diagnostics. In that case, all the pre-market review, compliance review, and medical device reporting (MDR) review functions for in vitro diagnostics were combined into one office under a single management team. The total product lifecycle regulatory approach, she explained, “allows people to see the lifecycle of activities …

ReWalk Announces Progress with German Statutory Health Insurer to Provide Coverage of Robotic Exoskeletons for Individuals With Spinal Cord Injuries | PR Newswire | 3/18/2020

… ReWalk’s ability to repay its secured indebtedness; ReWalk’s ability to improve its products and develop new products; the outcome of ongoing shareholder class action litigation relating to its initial public offering; ReWalk’s compliance with medical device reporting regulations to report adverse events involving the Company’s products, which could result in voluntary corrective actions or enforcement actions such as mandatory recalls, and the potential impact of such adverse events on ReWalk’s …

World Smart Biopsy Devices Market Outlook to 2023: Revenue Forecasts, Issues & Trends, Major Player Profiles, Regional Dynamics | PR Newswire | 3/18/2020

… Executive Summary Chapter 3 Market Overview Introduction Market Potential Market Share Regulatory Framework Establishment Registration and Medical Device Listing Premarket Notification 510(k) Premarket Approval Investigational Device Exemption (IDE) Quality System Regulation Labeling Requirements Medical Device Reporting (MDR) Growth Drivers and Trends Increasing Prevalence of Cancer Increasing Number of Cancer Research Studies Advancement of Biopsy Procedures and Adoption of Minimally Invasive Biopsy Procedures Chapter 4 Smart Biopsy Device Applications Overview …

U.S. Medical Devices Regulatory Intelligence Report 2020 | PR Newswire | 3/11/2020

… of Federal Regulations (CFR) eCFR Premarket Notification 510(k) Clearance to Market 510 (k) Exempt Devices PMA (Pre-Market Approval) Good Manufacturing Compliance (GMP) Compliance Establishment Registration Device Registration and Listing Labelling Requirement Advertising Medical Device Reporting (MDR) Local Agent Requirements Responsibilities of the US agent Medical Device User Fee List of Tables Table 1: Class I and Class II Exempt Devices Table 2: Medical Device User Fee Amendments (MDUFA …

Patient Safety: BD Provides Update on Feb. 4, 2020 Voluntary Recall of the BD Alaris™ System PC Units and Modules | 3/11/2020

… to those recall instructions. This recall, which BD announced on Feb. 4, 2020 , has been designated as a Class I recall by the U.S. Food and Drug Administration (FDA) and has been associated with medical device reporting (MDR) submissions. This FDA classification does not change the guidance BD provided in the company’s February recall announcement to customers. BD initiated the voluntary recall to notify customers of five issues where the …

BD Provides Update on Feb. 4, 2020 Voluntary Recall of the BD Alaris™ System PC Units and Modules | 3/10/2020

… to those recall instructions. This recall, which BD announced on Feb. 4, 2020 , has been designated as a Class I recall by the U.S. Food and Drug Administration (FDA) and has been associated with medical device reporting (MDR) submissions. This FDA classification does not change the guidance BD provided in the company’s February recall announcement to customers. BD initiated the voluntary recall to notify customers of five issues where the …

Crwe World | BD Provides Update on Feb. 4, 2020 Voluntary Recall of the BD Alaris™ System PC Units and Modules | 3/9/2020

… to those recall instructions. This recall, which BD announced on Feb. 4, 2020 , has been designated as a Class I recall by the U.S. Food and Drug Administration (FDA) and has been associated with medical device reporting (MDR) submissions. This FDA classification does not change the guidance BD provided in the company’s February recall announcement to customers. BD initiated the voluntary recall to notify customers of five issues where the …

Effective Complaint Handling, Medical Device Reporting and Recalls (Baltimore, MD, United States - March 19-20, 2020) - ResearchAndMarkets.com | Malvern Daily Record | 1/24/2020

The “Effective Complaint Handling, Medical Device Reporting and Recalls” conference has been added to ResearchAndMarkets.com’s offering. An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint …

Effective Complaint Handling, Medical Device Reporting and Recalls (Baltimore, MD, United States – March 19-20, 2020) – ResearchAndMarkets.com | Financial Buzz | 1/24/2020

The “Effective Complaint Handling, Medical Device Reporting and Recalls” conference has been added to ResearchAndMarkets.com’s offering. An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint …

FDAnews Announces —17th Annual Medical Device Quality Congress April 20-22, 2020 - Bethesda, MD | PRWeb | 1/22/2020

… EU-IVDR) — what one must know to obtain a CE Mark QMS under EU-MDR and EU-IVDR — create a foolproof QMS Complaint reporting — save time and money by avoiding resubmission requests with US medical device reporting (MDR) and EU-MDR’s/IVDR’s new manufacturer’s incident report (MIR) Corrective actions — US and EU perspectives, including EU-MDR/IVDR field safety corrective actions (FSCAs), field safety notice (FSN) and other reports one …

RAQA Compliance Analyst - USA-FL-Fort Lauderdale | 1/10/2020

Responsibilities: Effectively supports complaint handling process and processes complaints in a uniform and timely manner. Evaluate complaints to determine whether an investigation is necessary in accordance with 21 CFR Part 803 Medical Device Reporting , Canadian regulations, European Vigilance Reporting and any other worldwide regulatory requirements. Facilitates the timely initiation of complaints and closure of complaint investigations Develop, prepare, and analyze trend reports for Complaints/ MDR monthly or quarterly as required …

“Medical Device Compliant Management Services Market Worth $576.34 Million in 2019”, says Visiongain report | 1/8/2020

08 January 2020 Pharma Visiongain’s new report the Medical Device Compliant Management Services Market Report 2019-2029 : Forecasts by Service (Complaints Log (Receive Complaints, Classify Issue, Record Issue), Product Surveillance & Regulatory Compliance (Reportable/Non Reportable, Medical Device Vigilance/Medical Device Reporting, Field Action), Returned/ Non-Returned Product Analysis (Complaint Investigation, Root Cause Testing, Preventive Action), Resolve Log ( Complaint Summary, Customer Letter Creation)), plus analysis indicates that the global Medical Device Compliant …

2020 Medical Device Reporting: What You Need to Know (New Regulations + Stats) | 1/2/2020

The medical and pharmaceutical field is about to get much more complicated — specifically for companies operating in the EU. In May of 2020, new Medical Device Reporting (MDR) regulations will be implemented throughout Europe. These new regulations — which are four-times longer than previous European medical device regulations — are aimed at improving patient safety. But, as you’ll see later on, the increase in regulations isn’t unique to the EU. Across …

Q&R Project Manager (Medical Device Reporting) | 11/21/2019

… term opportunities to advance your career with the latest emerging technologies. Work Summary: The Q&R Project Manager (Medical Device Reporting) provides operational leadership over a project mainly dedicated to improving the processes behind medical device reporting and service order reporting. They are accountable for the development, delivery, and scheduling of the project, in accordance to quality and regulatory demands and compliance requirements. The role requires specialized technical working experience …

Abiomed Medical Office Completes Review of Observational Analysis of Impella Presented at AHA – Company Announcement - FT.com | Financial Times | 11/19/2019

… from more than 215 publications, totaling 1,638 Impella patients. Further data was provided from 637 high-risk patients enrolled in the U.S. Impella registry, now called the cVAD Study. The submission also incorporated a medical device reporting analysis from approximately 14,000 Impella patients at the time. In February 2018 , Impella’s FDA PMA was expanded to include patients with mild or moderately reduced ejection fraction. The data submitted to the FDA …

Abiomed Medical Office Completes Review of Observational Analysis of Impella Presented at AHA - Business Wire | 11/19/2019

… from more than 215 publications, totaling 1,638 Impella patients. Further data was provided from 637 high-risk patients enrolled in the U.S. Impella registry, now called the cVAD Study. The submission also incorporated a medical device reporting analysis from approximately 14,000 Impella patients at the time. In February 2018, Impella’s FDA PMA was expanded to include patients with mild or moderately reduced ejection fraction. The data submitted to the FDA …

K-Bar List Jobs: 7 Nov 2019 | 11/7/2019

… 19124691 – Job Summary: The QA/RA MDR Analyst supports all Hill-Rom entities globally in determining reportability of complaints and ensuring on time regulatory reporting. Essential Duties and Responsibilities: Manage and maintain an efficient Medical Device Reporting work flow in order to achieve complete, accurate and timely medical device reporting. Draft and file Medical Device Reports to the US FDA, as well as support international teams to ensure all regulatory …

(USA-UT-Sandy) Quality System Specialist III | 11/2/2019

… MDR’s associated with complaints to the FDA. Job Description Responsibilities Interact and communicate with other team members and Quality Business Leadership/Customers, Consumers and other Professionals regarding Product Quality concerns and issues related to medical device reporting . Responsible for new and existing product and process training. Responsible for development and roll out of MDR guidelines as needed. Demonstrate good documentations practices. Maintain in-depth knowledge of Company, Department, and Quality …

(CHN-Shenzhen) Complaint Specialist (AEC-ECR) | 10/31/2019

… to As an AEC ( Adverse Event Coordinator) , you will support MDR (Medical Device Regulation)/adverse event reporting, triage complaint records, manage high-risk complaints to CA (Competent Authority). You are responsible for Ensures timely medical device reporting by assessing complaints against reporting requirements and facilitating any required further investigation. Write and submit medical device reports (MDRs) and / or regulatory reporting. Works with a variety of diverse persons within the company …

Food and Drug Administration

FDA Issues Warning Letter to Battelle Memorial Institute, a Manufacturer of an Authorized Decontamination System Used on Respirators | 10/7/2020

SILVER SPRING, Md. , Oct. 7, 2020 /PRNewswire/ – Today, the U.S. Food and Drug Administration (FDA) issued a warning letter to Battelle Memorial Institute for failure to comply with regulatory requirements for medical device reporting as specified in the Emergency Use Authorization (EUA) for the Battelle Critical Care Decontamination System. “It is critical that manufacturers have an effective process in place for reporting adverse events related to the use of authorized …

FDA Approves Cardiovascular Systems' Coronary ViperWire Advance With Flex Tip | 11/4/2019

U.S. approval of the rirst and only Nitinol Atherectomy Guide Wire expands the company’s portfolio of products targeting complex coronary disease. Related CONTENT FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting Business Wire 11.04.19 Cardiovascular Systems Inc., a medical device company developing and commercializing interventional treatment systems for patients with peripheral and coronary artery disease, has received U.S. Food and Drug Administration (FDA) PMA approval of …

Patient Safety

FDA Opens Confidential Medical Device Problem Database to Public | HIT Infrastructure | 6/24/2019

… MORE: Medical Device Networks Need Biomedical, IT Department Consolidation The moves were part of the FDA’s announced update to its medical device reporting (MDR) program, which the agency uses to monitor device performance, detect device … algorithms to evaluate large data sets on device performance and patient safety associated with device use in routine clinical practice. In FY 2019, Congress provided funding to begin to develop active surveillance capabilities for NEST …

Statement from Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, on agency’s efforts to increase transparency in medical device reporting | PR Newswire | 6/21/2019

… Food and Drug Administration’s Center for Devices and Radiological Health is taking a number of important steps to update its Medical Device Reporting (MDR) Program, one of the tools the FDA uses to monitor device … algorithms to evaluate large data sets on device performance and patient safety associated with device use in routine clinical practice. In FY 2019, Congress provided funding to begin to develop active surveillance capabilities for NEST …

Larry Jasinski

ReWalk Announces Progress with German Statutory Health Insurer to Provide Coverage of Robotic Exoskeletons for Individuals With Spinal Cord Injuries | PR Newswire | 3/18/2020

… procurement by the insurer, patients will be able to take home a device for daily personal use,” said ReWalk CEO Larry Jasinski . “We are so pleased to get these devices to people who need them … litigation relating to its initial public offering; ReWalk’s compliance with medical device reporting regulations to report adverse events involving the Company’s products, which could result in voluntary corrective actions or enforcement actions such as mandatory …

FDA Issues Clearance for the ReStore™ Exo-Suit, the First Soft Robotic System for Stroke Therapy | PR Newswire | 6/4/2019

… a functional and affordable system that can be utilized in the ‘Main Street’ clinics in every community,” said ReWalk CEO Larry Jasinski . “With a launch price of $28,900 as well as leasing options, ReStore offers … litigation relating to ReWalk’s initial public offering; ReWalk’s compliance with medical device reporting regulations to report adverse events involving its products and the potential impact of such adverse events on ReWalk’s ability to market and …

Laura Wood

U.S. Medical Devices Regulatory Intelligence Report 2020 | Markets Insider | Business Insider | 3/11/2020

… Exempt Devices PMA (Pre-Market Approval) Good Manufacturing Compliance (GMP) Compliance Establishment Registration Device Registration and Listing Labelling Requirement Advertising Medical Device Reporting (MDR) Local Agent Requirements Responsibilities of the US agent Medical Device User … focused, comprehensive and tailored research. Media Contact: Research and Markets Laura Wood , Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 …

U.S. Medical Devices Regulatory Intelligence Report 2020 | PR Newswire | 3/11/2020

… Exempt Devices PMA (Pre-Market Approval) Good Manufacturing Compliance (GMP) Compliance Establishment Registration Device Registration and Listing Labelling Requirement Advertising Medical Device Reporting (MDR) Local Agent Requirements Responsibilities of the US agent Medical Device User … focused, comprehensive and tailored research. Media Contact: Research and Markets Laura Wood , Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 …

Kathleen O'Donnell

ICYMI: ReWalk’s Restore technology for stroke patients featured in MD | PR Newswire | 11/30/2017

… assistive medical devices, and outlines the inspiration for a soft suit exoskeleton, with interviews with ReWalk CEO Larry Jasinski and Kathleen O’Donnell , lead of the medical exosuit program at Harvard’s Wyss Institute, ReWalk’s collaborative partner … be delisted if it cannot do so; ReWalk’s compliance with medical device reporting regulations to report adverse events involving its products and the potential impact of such adverse events on ReWalk’s ability to market and …

ICYMI: ReWalk’s Restore technology for stroke patients featured in MD | PR Newswire | 11/30/2017

… assistive medical devices, and outlines the inspiration for a soft suit exoskeleton, with interviews with ReWalk CEO Larry Jasinski and Kathleen O’Donnell , lead of the medical exosuit program at Harvard’s Wyss Institute, ReWalk’s collaborative partner … be delisted if it cannot do so; ReWalk’s compliance with medical device reporting regulations to report adverse events involving its products and the potential impact of such adverse events on ReWalk’s ability to market and …