Navigation Links
New BSI CE-Onsite Facilitates CE Marking Reviews for Device Manufacturers
Date:3/26/2009

RESTON, Va., March 26 /PRNewswire/ -- As a direct response from client feedback, BSI launches a new speed-to-market program, CE-Onsite FastTrack Review, for Class III medical devices needing European CE Marking Design Dossier Reviews. This new program will expedite the review process through live, onsite interaction, facilitating more efficient communication as well as the goal of completing the review in 45 working days.

The CE-Onsite has the same features of the CE-45 FastTrack Program, with one main difference: BSI Product Experts visit the manufacturer's premises to perform the review. As an industry norm, reviews are conducted via mail, email, fax and telephone and the process can take months. However, performing reviews onsite allows for a much faster timeline while still maintaining the same high quality. This face-to-face opportunity provides Product Experts accessibility to all relevant parties, from engineers to regulators, and supports dynamic communication, immediate access to documentation and in-person viewing of the new product.

This new premium program is not for everyone or every product. As with the CE-90 and CE-45 programs, some products such as medicinal, blood and animal tissue products, require the use of outside agencies and may not be eligible for CE-Onsite Review. In addition, while BSI's goal is to complete the review with either a positive or negative recommendation within 45 working days, the length of the review greatly depends on the degree to which the manufacturer is prepared. In order to make the review as effective as possible, clients should have a strong motivation to get their product to market and excellent documentation, and be well-organized and responsive to questions. Manufacturers utilizing the CE-Onsite have experienced numerous advantages including shorter launch times, patients gaining access to new technology sooner and quicker return on investment.

"The interact
'/>"/>

SOURCE BSI
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Brotman Medical Center Facilitates Restructuring Through Chapter 11 Filing
2. Optimal band imaging with endoscopy facilitates the diagnosis of depressed-type early gastric cancer
3. Interview by Internet Can Decrease Greatest End-of-Life Fears: It Facilitates Creating Effective Advance Directives, Living Wills
4. Misys Facilitates Masraf Al Rayans Expansion of Islamic Banking Operations
5. ACS Facilitates Emergency Prescription Assistance Program Now Activated in Southern Louisiana
6. TeleHealth Services TIGR(R) Interactive Patient Education System Facilitates Award-Winning Results at Northridge Hospital Medical Center
7. Chamberlain Group Surgical Training Model Facilitates New Treatment for Chronic Rhinosinusitis
8. The Integrated Benefits Institute Offers Largest Benchmarking Database in U.S. Spanning Disability and Workers Compensation Programs
9. BeneChills RhinoChill System Receives CE Marking for European Commercial Sale
10. ANSYS Expands HPC Benchmarking Program
11. Global Benchmarking Council Launches New Virtual Tour of Research & Networking Service
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/29/2014)... HealthDay Reporter TUESDAY, ... take on a task, various brain connections fire up. ... kids with autism, according to a small new study. ... displayed even less of this "brain flexibility," the researchers ... difficulty when children with autism are faced with new ...
(Date:7/29/2014)... As the Ebola outbreak in Liberia worsens, PCI (Project ... critical emergency supplies locally, as well as ship a donation ... contain materials used to control the spread of the disease ... country. , With a large programmatic presence in Liberia, ... outbreak in the region. The current epidemic remains serious: the ...
(Date:7/29/2014)... 29, 2014) Using quality improvement measures in eight ... Cardiovascular Disease Study Group, researchers have found a way ... with contrast dye. , Currently, 7-15 percent of these ... end up with kidney injury, which can result in ... temporary or permanent dialysis, says a study published in ...
(Date:7/29/2014)... York (PRWEB) July 29, 2014 ... of individuals who allegedly suffered serious liver injuries ... to move forward in a multidistrict litigation underway ... Bernstein Liebhard LLP reports. According to an Order ... certain deadlines pertaining to bellwether case and discovery ...
(Date:7/29/2014)... HealthDay Reporter TUESDAY, July 29, ... just a single dose of the hormone oxytocin quickly improved ... report. Known as the "love hormone," oxytocin has been ... and between mothers and their children. In this study, ... the brain that has long been associated with the processing ...
Breaking Medicine News(10 mins):Health News:Less Flexibility Seen in Brain Wiring of Kids With Autism: Study 2Health News:Less Flexibility Seen in Brain Wiring of Kids With Autism: Study 3Health News:PCI Responds to Ebola Outbreak in Liberia with Supplies, Awareness Campaigns 2Health News:PCI Responds to Ebola Outbreak in Liberia with Supplies, Awareness Campaigns 3Health News:Reducing kidney injury using a quality improvement method 2Health News:Tylenol Lawsuit News: Federal Court Overseeing Tylenol Liver Damage Claims Sets New Deadlines Pertaining to Discovery, Bellwether Trials, Bernstein Liebhard LLP Reports 2Health News:Tylenol Lawsuit News: Federal Court Overseeing Tylenol Liver Damage Claims Sets New Deadlines Pertaining to Discovery, Bellwether Trials, Bernstein Liebhard LLP Reports 3Health News:Tylenol Lawsuit News: Federal Court Overseeing Tylenol Liver Damage Claims Sets New Deadlines Pertaining to Discovery, Bellwether Trials, Bernstein Liebhard LLP Reports 4Health News:'Love Hormone' Oxytocin May Help Some With Autism 2Health News:'Love Hormone' Oxytocin May Help Some With Autism 3
... of Minnesota,s Institute for Mathematics and its Applications (IMA) ... renewal grant over the next five years. The renewal ... nation,s top math institutes in terms of funding. ... Minnesota,s College of Science and Engineering, is one of ...
... WEDNESDAY, Aug. 25 (HealthDay News) -- Two of the ... connection, with new research suggesting that having insulin resistance or ... plaques associated with Alzheimer,s disease. After adjusting for other ... highest levels of fasting insulin had nearly six times the ...
... In real estate, location is everything. The same might be said ... as building blocks for cells and as key energy sources for ... issue of the Journal of Lipid Research, a team ... Diego School of Medicine, has mapped for the first time the ...
... Gardner HealthDay Reporter , WEDNESDAY, Aug. 25 ... Monday,s decision by a U.S. judge to halt any ... The temporary injunction, which basically blindsided the scientific community, ... pre-2001 days. That was when then-President George W. Bush ...
... One in seven patients experience more pain, physical and emotional ... a quarter have less vitality. Those are the key findings ... online by the British Journal of Surgery . ... 185 men with an average age of 54, who had ...
... at Mayo Clinic discovered several years ago that laboratory samples ... to help them find new treatments for this lethal disease ... became evident that the situation in their lab was common ... that were supposed to originate from patients with this rare ...
Cached Medicine News:Health News:University of Minnesota math institute receives $20.5 million NSF grant 2Health News:Link Between Diabetes, Alzheimer's Disease Strengthened 2Health News:Link Between Diabetes, Alzheimer's Disease Strengthened 3Health News:Link Between Diabetes, Alzheimer's Disease Strengthened 4Health News:Where the fat's at 2Health News:Obama to Appeal Stem Cell Ruling 2Health News:Obama to Appeal Stem Cell Ruling 3Health News:Up to 1 in 4 patients report more physical problems a year after surgery than before 2Health News:Mayo researchers develop new laboratory cell lines to study treatment for ATC 2Health News:Mayo researchers develop new laboratory cell lines to study treatment for ATC 3
(Date:7/29/2014)... BEDFORD, Mass. , July 29, 2014  Instrumentation Laboratory ... identity, including a new corporate logo. This is part of ... IL. Founded in Boston, MA ... Group family of companies since 1992.  Other companies in the ... ), Biokit and Systelab ( Barcelona, Spain ).  ...
(Date:7/29/2014)... July 29, 2014  Sysmex America, Inc., a global ... technology, will feature an exhibit booth during the ... Clinical Lab Expo in Chicago ... "We are extremely excited to exhibit at AACC ... with our customers and continue the dialogue on how ...
(Date:7/29/2014)... CITY , July 29, 2014  The ... Grand American Hotel in Salt Lake City ... representing some of most respected healthcare organizations in the ... Catalyst , is an industry conference devoted to providing ... analytics,  an essential element of both accountable care initiatives ...
Breaking Medicine Technology:Instrumentation Laboratory Unveils New Corporate Brand 2Instrumentation Laboratory Unveils New Corporate Brand 3New Product Offerings Highlight Sysmex's Presence at 2014 AACC in Chicago 2New Product Offerings Highlight Sysmex's Presence at 2014 AACC in Chicago 3Health Catalyst Adds Keynote Speakers, New Sessions, and Expands Attendee Limit for Healthcare Analytics Summit 2014 2Health Catalyst Adds Keynote Speakers, New Sessions, and Expands Attendee Limit for Healthcare Analytics Summit 2014 3Health Catalyst Adds Keynote Speakers, New Sessions, and Expands Attendee Limit for Healthcare Analytics Summit 2014 4Health Catalyst Adds Keynote Speakers, New Sessions, and Expands Attendee Limit for Healthcare Analytics Summit 2014 5
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: