'Medical device manufacturers' presentation slideshows

Workflow Resource Allocation through Auctions

780 views • 64 slides

Europe

Europe. Overview of Actors and Roles. Manufacturer. Competent Authority. Notified Body. European Commission and Member States. Certification and Audits (Inspections). Registrations Surveillance Enforcement. Designation Surveillance Enforcement.

817 views • 53 slides

Teaching Professionalism to Residents: The Management of Conflict of Interest in Medicine

553 views • 44 slides

Shedding Some Fair Market Value Light on the Sunshine Act

295 views • 29 slides

Agenda

Agenda. The role of MHRA, Hospitals and the Manufacturer Incident Reporting Signal Detection Medical Device Regulation Managing Medical Devices Devices in Diabetes Bed rails. The role of MHRA, Hospitals and the Manufacturer in adverse incident reporting. .

412 views • 26 slides

Investigator Grant Payments are Not Just a Site Concern Anymore February 8, 2011

397 views • 25 slides

Bluetooth Medical Device Profile (MDF)

Bluetooth Medical Device Profile (MDF). Introduction. January 2006 a workgroup was formed to develop standard to support existing and emerging medical devices and to bring compatibility and interoperability.

326 views • 19 slides

Product Safety & Failure Analysis

Product Safety & Failure Analysis. Lina Elsamaloty Jessi FredERICKS. Introduction. Safety Standards Designed to ensure the safety of products, activities, and processes Enforced by an advisory or regulatory body Safety Organizations International Organization of Standardization (ISO)

388 views • 18 slides

Al Taylor Acting Chief, Medical Electronics Branch Office of Science and Technology

FDA Regulatory Perspectives Presented to the Philadelphia Area Medical Instrumentation Association. Al Taylor Acting Chief, Medical Electronics Branch Office of Science and Technology February 24, 2004. Who am I?. Alford R. Taylor, Jr. Acting Chief, Medical Electronics Branch

275 views • 16 slides

Use of Standards in the Regulatory Regime: Canadian Experience

Use of Standards in the Regulatory Regime: Canadian Experience. David Shortall Standards Council of Canada. Purpose of the presentation. Explain Canadian policies on referencing standards in regulations and the role of the Standards Council of Canada in this process

270 views • 15 slides

How to implement of FMEA with ISO 14971

Failure Mode and Effects Analysis (FMEA) is a core aspect of risk management and risk analysis in medical devices. FMEA is essentially about analyzing the reasons for which a problem arises and the effects it has on the system. In the field of medical devices, it is absolutely critical to understand the failure mode and effects because the consequences of not doing this can be disastrous and many times, even fatal.

427 views • 9 slides

New Medical Device Regulations - EU MDR

Within the medical devices industry, professionals have long been exercising acquiescence with regards to the new European Medical Device Regulation (MDR). At last, after a very lengthy process the MDR was finalized and it was duly published in the Official Journal of the European Union on 5th May, 2017.

1.84k views • 8 slides

medical device manufacturing in continuous improvement program

Operon Strategist is implementing an enhanced continuous Improvement Program (CIP) in response to the feedback that clients have provided to us, about their engagement processes and areas for their performance improvement. Contact details u2013 Phone no - 9325283428 Mail - dm@operonstrategist.com Visit - https://www.operonstrategist.com/continuous-improvement-program/?utm_source=ppt and pdf submission&utm_medium=ppt and pdf page&utm_campaign=ppt and pdf submission

85 views • 8 slides

EU Medical Device Regulation

629 views • 7 slides

Product Complaints: Complaint Handling from Intake to Closure

An effective complaint handling system is an extremely important part of any quality system whether you are a medical device or pharmaceutical manufacturer. 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. Manufacturers must ensure that they have a well-designed system to address complaints related to their products. Components of a well-designed system include: process/procedure, trained personnel, and proper record keeping. Complaint handling is no easy task. Management might overlook the importance of customer feedback and be unable to capture all complaints coming from disparate sources. Plus, the additional regulatory reporting requirement related to adverse events may seem overly burdensome to device makers in particular. A strategic risk-based methodology can help streamline the complaint-handling process in medical device manufacturing.

188 views • 5 slides

The Challenging World Of Medical Device Companies Face

The medical device companies have a market where the demand is very high today. The medical devices are used by every medical service provider.

109 views • 1 slides

Highest Level Of Quality Measures For Medical Device Companies

Today, the world of medical device companies has changed a lot. The new regulations from the governments and the medical boards have forced the companies to manufacture devices with the highest level of quality measures.

95 views • 1 slides

Authorized EU Representative for Design Dossier and Free Sale Certificate at Qualimedtech

Design Dossier for Medical Device requires implementation of the quality management system.

33 views • 1 slides

Innovations in Cellular Medical Care Services Help Assisting Medical Device Manufacturers

Printec has earned a global reputation for its excellence in designing and manufacturing Human Interface Devices.

19 views • 1 slides