Navigation Links
Sparta Systems(TM) Outlines Tips and Tactics to Prepare for eMDR Mandate
Date:6/16/2009

Suggested Best Practices will Prepare Medical Device Manufacturers to Comply with Expected Legislation and Drive Continued Innovation of Critical Healthcare Products

HOLMDEL, N.J., June 16 /PRNewswire/ -- Sparta Systems, Inc., the maker of TrackWise(R) software and the market leader in enterprise quality and compliance management solutions, today outlined its recommendations to help companies prepare for electronic Medical Device Reporting (eMDR), the expected regulation from FDA Center for Devices and Radiological Health (CDRH). The mandate will require electronic filing of safety reports for medical device organizations.

Understanding the daunting challenges presented to medical device companies in transitioning to an electronic submission system, Sparta Systems has developed a multi-step approach that organizations can employ to prepare for the eMDR legislation in advance of the regulatory mandate. These strategies will arm organizations for compliance with the legislation when eMDR reporting is mandated, with tactics geared specifically toward thought, planning, design, testing and, ultimately, implementation.

Sparta Systems has been in close communication with the FDA as the proposed legislation has been refined, and proactively provides its customers with an enterprise-wide quality management system that allows for a seamless transition from the current paper-based system to an electronic submission model. These suggestions for proactive eMDR compliance will not only help reduce associated compliance costs, but should also serve to streamline manufacturing processes, help ensure the safety of medical devices and foster customer loyalty. These suggestions include:

  1. Thought - Before any system can be designed, a thorough, candid self-evaluation is required for companies to understand the scope and nature of their businesses' eMDR needs. Initially considering these vital questions will lay the foundation for a successful transition before any planning or design has been implemented.
  2. Planning - After the current MDR methodology has been reviewed and a needs analysis conducted, the next step is to plan the transition from the old system to the new one. During this review, common processes should be leveraged and divergent processes isolated and documented. At the end, the actual method and means of receiving, transmitting and auditing data will be critical.
  3. Design - Design of an eMDR system should bring together all the elements discussed and reviewed throughout the thought and planning phases. Designing an effective system that includes these elements working in proper order and alignment will result in reduced time and costs spent testing and, finally, implementing the final eMDR solution.
  4. Testing - Once a system has been designed that will theoretically satisfy eMDR requirements, the next step is to test it. Possible failure scenarios should also be tested to ensure that the appropriate action takes place in the system when the failure is identified.
  5. Implementation - Finally, when all the necessary steps have been completed, and the system has been thoroughly tested, implementation can occur. Careful observation of eMDR users and approvers is important to ascertain that they are adhering to correct procedures and that reports are being submitted and filed in a timely manner.

"Whether organizations like it or not, eMDR is coming, and it is in the best interest of companies of all sizes to begin their preparations for electronic submission now, before they no longer have the option," said Mike Jovanis, vice president of product management, Sparta Systems. "Sparta Systems is committed to helping our customers ensure a smooth transition to this electronic submission process, and the enhanced reporting functionality in our TrackWise software can make this transition as simple and painless as possible."

To learn more about eMDR and receive thorough preparation guidelines, click here. For a complete overview of Sparta Systems and TrackWise software, visit www.spartasystems.com.

Sparta Systems and TrackWise are trademarks or registered trademarks of Sparta Systems, Inc. All other marks are trademarks of their respective companies.

    Press Contact
    Jon Rabinowitz
    Sparta Systems
    732-203-0400
    jonr@spartasystems.com

    Press Contact
    Katy Zack
    Articulate Communications Inc.
    212.255.0080, ext. 11
    kzack@articulatepr.com


'/>"/>
SOURCE Sparta Systems, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Evidence-Based Analysis of Aspartame Research
2. Sparta Systems Launches Hong Kong Operations to Drive Enterprise Quality and Compliance in Asia-Pacific Region
3. S-Shaped Light Display on Blue Cross Blue Shield of Michigan Building Shows Support for MSU Spartans
4. Sparta Systems Strengthens TrackWise(R) Enterprise Class Quality Management Solution with Robust Web Services Capabilities
5. Sparta Systems to Address Critical Electronic Medical Device Reporting (eMDR) Concerns with Free Webinar
6. Spartan Stores Becomes Largest U.S. Supermarket Chain to Receive NSF Shop Fresh(TM) Certification
7. New Expert Report Dispels Common Myths About Aspartame
8. Aspartame is safe, study says
9. New Study of Aspartame Research Reaffirms Safety, Even Among Heaviest Users
10. RADinfo SYSTEMS(TM) Completes a Massive 22 Clinic Urgent Care PACS Installation
11. RADinfo SYSTEMS(TM) is Pleased to Introduce Their Newly Established Division, VETinfo SYSTEMS(TM)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/24/2017)... ... ... “Finding Christ Through Social Media: Year One #A365DayJourney to ... path toward true communion with God. “Finding Christ Through Social Media: Year One ... published author Lea Michelle Johnson, a follower of Christ, wife and mother who ...
(Date:3/24/2017)... ... March 24, 2017 , ... “The Communion of Saints: ... of God in congregations across the United States. “The Communion of Saints” ... 1964 who has served congregations in seven states throughout his long career of ...
(Date:3/23/2017)... ... ... A recent report from the National Council on Teacher Quality (NCTQ) advocates ... based on a review of GPA and SAT/ACT requirements at 221 institutions in 25 ... argues that this higher bar should be set by states, by the Council for ...
(Date:3/23/2017)... Braunfels, TX (PRWEB) , ... March 23, 2017 , ... ... new clinic, located at 960 Gruene Road in Building 2. The clinic is the ... Dr. Andrew Bennett, PT, says opening the company’s second New Braunfels location brings things ...
(Date:3/23/2017)... ... ... The MBI “Hall of Fame” recognizes the contributions of those whose careers are or were ... careers of all others involved. , On Monday, March 21st, 2017 Laurie Robert, ... Fame. The induction took place during the World of Modular – Award Gala in ...
Breaking Medicine News(10 mins):
(Date:3/24/2017)... YORK , March 24, 2017 ... and Equipment stocks, which are: Neovasc Inc. (NASDAQ: NVCN), Hologic ... Heart Inc. (NASDAQ: SSH ). These companies are ... its prior gains on Thursday, March 23 rd , 2017, ... afternoon, while shares of health care companies in the S&P ...
(Date:3/24/2017)... 2017  HealthMine surveys with 9,250 insured consumers fielded ... plan members want help from their plans in five ... their health, 2) help closing gaps in care, 3) ... and 5) relevant, real-time guidance. Meeting these needs is ... A Reason to Stay Engaged ...
(Date:3/24/2017)... The Board of Directors of Nordic Nanovector ASA (OSE: ... complete 2016 Annual Accounts with notes. The report is attached ... the section Investor Relations/Reports and presentations/Annual Reports. ... For further information, please ... Cell: +47-91-51-95-76 Email: ir@nordicnanovector.com Media enquiries: ...
Breaking Medicine Technology: