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.’
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 step in Pico-Tesla demonstrating conformance to medical device safety and effectiveness requirements, thus strengthening the Company’s ability to enter worldwide markets.
Pico-Tesla CEO Allen Braswell said receiving the ISO 13485 certification bears strong witness to the significant progress they are making toward establishing the clinical application of Magneceutical Therapy for Parkinson’s and other difficult-to-treat diseases.