|
News & Events
Postmarket Is CDRH's Top Priority, Official Says
See the FDAnews Device Daily Bulletin Vol.5 No. 104.
Of all CRO's listed in the Applied Clinical Trials, Factory is the only CRO outside the US, specialized in Medical Devices
Factory is not only the best CRO but also the “fastest.”
On March 15 the Factory CRO was the winner of the 10 kilometer run during the Fortis City-Pier-City business run in The Hague where more than 500 teams started. View the picture.
Factory is mentioned in the MX journal as the firm with established expertise in clinical research for Medical Technologies
In an article at the 'MX Business Strategies for Medical Technology Executives', Factory is as only European CRO mentioned as a firm which has established expertise in clinical research
for Medical Technologies. For more information about the MX journal visit the following website www.devicelink.com/mx
Factory is cosponsor at the MedTech Insight 'Investment in Innovation: Medical Device Summit'
This two-day event is the largest east-coast strategic partnership and investment meeting for Medical Technology Executives.
For more information about the program please visit the main sponsor website at www.medtechinsight.com
Joris Bannenberg wrote an article for GOR journal about trials on Medical Devices: Complying with ISO14155
In issue 1 of the GOR (Journal for the Medical, Pharmaceutical and Biotechnoloy Industries) you can read how Joris Bannenberg,
COO and Medical Doctor of Factory explains how studies on Medical Devices in humans need to be conducted in compliance with an international
quality standard, ISO14155. For more information about GOR journal, see www.gorjournal.com
Factory is cosponsor at the MedTech Insight 'Investment in Innovation: Medical Device Summit'
This two-day event is the largest strategic partnership and investment meeting for Medical Technology Executives.
For more information about the program please visit the main sponsor website at www.medtechinsight.com
Benefits of outsourcing to CRO’s
A survey by the Tufts Center for the Study of Drug Development shows that trials
with a high reliance on CROs stayed closer to schedule than those making less use
of CRO’s and trials that relied heavily on CRO participation submitted their data
to regulators more than 30 days closer to the project submission date than projects
with less CRO participation. Even larger, more complex trials are completed more
quickly when they have a high degree of CRO involvement. See for more information about
the survey
www.acrohealth.org
Factory-CRO is celebrating having 10 years the ISO 9001 certification
Factory is proud to be the first CRO Worldwide to obtain ISO9001 certification.
In Clinical Research Focus (Volume 16, Issue 9) Wendy Tomlinson RICR explains why it is so important for a CRO to have commitment to ISO9001:2000.
She tells that the ISO9001:2000 could be described not only as the ‘say what you do, do what you say’ approach,
but also to ‘review the effectiveness and strive to improve’ approach,
which focuses on spending time doing the right things extremely well.
Click here
for more information about CRFocus.
Factory is sponsor at the ACRP chaptermeeting “Conditions for Clinical research”
The Dutch Chapter is organising a meeting on the conditions of clinical research.
Topics are Trial compliance, Independent doctor, Patient information sheets,
Patient recruitment and Communication between site and sponsor. See for more information
www.acrpnet.org
Factory is cosponsor at the MedTech Insight’s “IN SPINE & ORTHOPEDICS: Strategic Partnering and Investing in Musculoskeletal Technology' Conference
This special event will provide a focused, single-track forum for a select group of
emerging spine and orthopedics companies to present to an audience of venture capitalists.
For more information about the program please visit the main sponsor website at
www.medtechinsight.com
12 Golden ISO14155 Rules for Medical Device Trials
by Prof David Hutchinson and Dr Joris Bannenberg
Guide for sponsors and investigators doing trials on medical devices. The 12 ‘golden rules’
presented help investigators comply with the globally applicable ISO 14155 standards entitled Clinical Investigation
of Medical Devices for Human Subjects (Parts 1 and 2). See for more information
www.canarybooks.com
Factory is cosponsor at the MedTech Insight 'Investment in Innovation: A Preview of Early-Stage Medical Technology Companies'
This two-day event will highlight emerging technologies being developed by more than 50 innovative start-up medical technology companiesÛfrom Europe and the U.S. For more information about the program please visit the main sponsorÌs website at www.medtechinsight.com
Joris Bannenberg will be a speaker at the ACRP 2005 European Conference & Exhibition
Together with John Webster, Joris Bannenberg will speak on the following subject: 'Medical Devices development within the context of the European Directive'. See www.acrpnet.org for more information.
Marianne Vink-de Man is our new Project Manager
Marianne has many years of experience with medical device trials, and recently worked as project manager for a large multinational biotech company.
|
