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Association Of Indian Medical Device Industry
CDSCO website which has been updated last month with Organization Chart (http://cdsco.nic.in/html/organisationalchart.htm)
and Draft Guidelines (http://cdsco.nic.in/Medical_div/medical_device_
division.htm)
The public comments are under compilation by CDSCO and a
review meeting is expected to take place in November end to enable finalization
and posting in December.
Responding to the growing market need for certification of
occupational health and safety management systems in Indian enterprises, the
National Accreditation Board for Certification Bodies (NABCB) of the QCI, as the
national accreditation body, has launched accreditation for OHSMS certification
bodies wef 1 Nov 2010. The information regarding the Scheme is available on the
website www. qcin.org.
Contact :
Forum Coordinator
Association of Indian Medical Device Industry (AIMED)
GL-3, Ashoka Estate, 24, Barakhamba
Road, New Delhi - 110001
Aastrom Forms Strategic Manufacturing &
Development Partnership With ATEK Medical
Aastrom Biosciences, Inc, a leading developer of expanded
autologous cellular therapies for the treatment of severe cardiovascular
diseases, and ATEK Medical, a leading medical device manufacturer, have formed a
new strategic partnership in which ATEK Medical will supply key components and
technology for use in Aastrom’s proprietary cell manufacturing process. This
partnership is intended to replace a previous supplier relationship with a more
comprehensive arrangement to strengthen Aastrom’s long-term manufacturing
capabilities. Aastrom plans to initiate its phase-3 CLI programme in 2011 and is
also developing its cell therapy for the treatment of dilated cardiomyopathy (DCM).
”Aastrom is a leader in developing new, proprietary cell
therapies to treat severe cardiovascular diseases. Their development programmes
and automated cell manufacturing system all require components that meet the
highest standards of cGMP and FDA compliance. Our technology expertise and
manufacturing experience for regulated products at ATEK make us an ideal partner
to support the technology needs of their advanced development programs,” said
Dave Mabie, ATEK Medical vice president of business development.
ATEK Medical specializes in product development and launch
based on advanced technology applications. Aastrom operates a cGMP facility in
Ann Arbor where the company’s automated, proprietary cell-manufacturing system
is used to produce expanded autologous cellular therapies based on a sample of a
patient’s bone marrow. The cell therapy produced by this process is then
delivered back to the same patient to promote regeneration of damaged tissues.
Aastrom Biosciences is developing expanded autologous
cellular therapies for the treatment of severe cardiovascular diseases.
ATEK Medical is a private, womanowned contract manufacturer
of disposable, implantable, and electromechanical medical devices.
http://www.pharmabiz.com/article/detnews.asp?
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