Healthcare Industry News: Parkinson’s disease
News Release - March 14, 2011
Pico-Tesla Achieves Significant Regulatory MilestoneCompany receives ISO 13485:2003 Quality Management System certification
“This event represents another big step for us toward establishing the clinical application of Magneceutical® Therapy.”
- Allen Braswell, CEO, Pico-Tesla
LITTLETON, Colo.--(Healthcare Sales & Marketing Network)-- Pico-Tesla, The Magneceutical® Company, has received the International Organization for Standardization (ISO) 13485:2003 certificate for the “design, development, production, manufacture and distribution of resonator systems that generate a low-level electromagnetic field for the therapeutic treatment of disease.”
ISO 13485:2003 specifies requirements for a Quality Management System whereby a company must demonstrate its ability to provide medical devices and related services that consistently meet the highest quality standards related to the clinical needs of patients and healthcare providers. The certification satisfies Health Canada as a pre-requisite for medical device distribution into Canada, and is also aligned to meet the requirements to the European Medical Device Directive (MDD) 93/42/EEC as amended by 2007/47/EC, to place the CE mark on its products. The certification is a significant step in Pico-Tesla demonstrating conformance to medical device safety and effectiveness requirements, thus strengthening the Company’s ability to enter worldwide markets.
“Receiving the ISO 13485 certification bears strong witness to the significant progress we are making toward establishing the clinical application of Magneceutical® Therapy for Parkinson’s and other difficult-to-treat diseases,” said Allen Braswell, CEO of Pico-Tesla.
“There is one thing that has stayed in my mind since getting involved with this opportunity. That is, to be so driven and committed to quality in such early stages of your product development is not a typical behavior of many companies, whether they are big or small. That commitment driven from the top can only bring continued success!” said Lynette Makowski, Principal Consultant, Achieving RA/QA Compliance LLC, a Regulatory and Quality Expert in the Medical Device Industry.
Pico-Tesla’s Magneceutical® Therapy is currently in clinical trials to determine its effectiveness for improving the signs and symptoms of several diseases, including Parkinson’s disease, atrial fibrillation, Alzheimer’s disease, fibromyalgia and osteoarthritis.
Privately held Pico-Tesla Magnetic Therapies is an emerging medical technology company with operations at: 7852 South Elati, Suite #202, Littleton, CO 80120 (303-795-3222); 4700 140th Avenue North, Suite #101, Clearwater, FL 33762; and, 27780 Novi Road, Suite 100, Novi, MI 48377 (248) 773-8969.
CAUTION: The Resonator™ device is an Investigational Device limited by federal (or United States) law to investigational use. The Resonator™ device is not for sale, nor is the Magneceutical® Therapy generally available outside of Investigational Review Board (IRB)-approved clinical studies.
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