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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?
articleid=58073&sectionid=

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