Saturday 19 March 2011

Pico-Tesla receives ISO certification for "Magneceutical Therapy"

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  fibromyalgia.
 http://www.news-medical.net/news/20110315/Pico-Tesla-receives-ISO-certification-for-Resonator-device.aspx

3 comments:

  1. Congratulations to Pico-Tesla for gaining an ISO certification. Other businesses should ISO Certification Training too because they have benefits for both the company's performance and it's product and services.

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  2. This ISO certification can be the most crucial and sensitive because it deals with health of its consumers. Being ISO 13485:2003 certified proves that a certain medical company uses medical devices in accordance to the standards that ISO had set. This, therefore, gives consumers a good image of a company. The company must maintain whatever medical devices it uses because ISO also checks the said requirements that the company uses to control the medical process.

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  3. This ISO Certification will assure patients that the products used in the medical service comply with the technical standards and regulations of the industry. Kudos to Pico-Tesla! Receiving ISO 13485:2003 certification will significantly help them build a credible reputation.

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