Medical Device Reporting

Selected news for the healthcare topic - Medical Device Reporting, collected since 10/2017. Recent stories appear in BioSpace and jdsupra.com. This healthcare topic shares news with Larry Jasinski, Food and Drug Administration, Patient Safety and many others.

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Date Headline (link) Source Relevant Snippet
10/7/2020 FDA Issues Warning Letter to Battelle Memorial Institute, a Manufacturer of an Authorized Decontamination System Used on Respirators BioSpace 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 ...
9/12/2020 FDA explains how EUA medical devices can electronically comply with AE reporting requirements jdsupra.com ... 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 ...
9/4/2020 FDAnews Announces —17th Annual Medical Device Quality vCongress, Wednesday, Oct. 7 – Thursday, Oct. 8, 2020 PRWeb ... 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 ...
7/16/2020 Complaint Systems Investigator – CONMED – Largo, FL medacura.com 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 ...
6/16/2020 How to get ISO 13485 certified, time for success? ... 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 ...
6/11/2020 Secant Medical Inc. 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 ...
4/2/2020 CDRH Reorganization Takes a Total Product Lifecycle Approach; MDSAP, ISO Adoption, and Collaboration with MDIC Moving Forward govzilla.com ... 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 ...
3/18/2020 ReWalk Announces Progress with German Statutory Health Insurer to Provide Coverage of Robotic Exoskeletons for Individuals With Spinal Cord Injuries PR Newswire ... 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 ...
3/18/2020 World Smart Biopsy Devices Market Outlook to 2023: Revenue Forecasts, Issues & Trends, Major Player Profiles, Regional Dynamics PR Newswire ... 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 ...
3/11/2020 U.S. Medical Devices Regulatory Intelligence Report 2020 PR Newswire ... 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 ...
3/11/2020 Patient Safety: BD Provides Update on Feb. 4, 2020 Voluntary Recall of the BD Alaris™ System PC Units and Modules afrinewsreportblog.com ... 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 ...
3/10/2020 BD Provides Update on Feb. 4, 2020 Voluntary Recall of the BD Alaris™ System PC Units and Modules fda.gov ... 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 ...
3/9/2020 Crwe World | BD Provides Update on Feb. 4, 2020 Voluntary Recall of the BD Alaris™ System PC Units and Modules crweworld.com ... 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 ...
1/24/2020 Effective Complaint Handling, Medical Device Reporting and Recalls (Baltimore, MD, United States - March 19-20, 2020) malvern-online.com 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 ...
1/24/2020 Effective Complaint Handling, Medical Device Reporting and Recalls (Baltimore, MD, United States – March 19-20, 2020) – ResearchAndMarkets.com financialbuzz.com 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 ...
1/22/2020 FDAnews Announces —17th Annual Medical Device Quality Congress April 20-22, 2020 - Bethesda, MD PRWeb ... 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 ...
1/10/2020 RAQA Compliance Analyst - USA-FL-Fort Lauderdale employmentcrossing.com 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 ...
1/8/2020 “Medical Device Compliant Management Services Market Worth $576.34 Million in 2019”, says Visiongain report visiongain.com 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 ...
1/2/2020 2020 Medical Device Reporting: What You Need to Know (New Regulations + Stats) chiefpackagingofficer.com 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 ...
11/25/2019 Francis Medical Appoints Chief Medical Officer mpo-mag.com ... medical officer of Francis Medical leading clinical and regulatory efforts of the minimally invasive treatment for prostate cancer. Image courtesy of Francis Medical. Related CONTENT FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting Business Wire 11.25.19 Francis Medical Inc., a Minneapolis-based, privately held medical device company developing a proprietary water vapor ablation therapy for the treatment of patients with prostate, kidney, and bladder cancer, has ...