"More Signal, Less Noise"
Innovation, quality, commitment, leadership, and service are the pillars of the ScanMed® of Resonance Innovations experience. As the industry leader for "patented" innovations of MRI coil technology, we bring more coverage and wide-spread clinical application with higher SNR. This is our "More signal, less noise" pledge.
Certifications
Commitment to quality and service is our top priority. Our innovations in coil concepts and designs put us at the front of imaging technology for magnetic resonance. Our focus is sharp and our standards are high.
ScanMed® has been independently audited and received ISO 9001:2000 and ISO 13485:2003 registrations. In addition, and more importantly, we have been certified by MR manufacturers as their OEM supplier. We are FDA registered. Our products are manufactured under strict defined control procedures that exceed the required standards of today's industry and regulatory agencies.
- ISO 9001:2000 - Quality Management Systems - Requirements
- ISO 13485:2003 - Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
- ISO 14971:2000 - Medical Devices - Application of Risk Management to Medical Devices
- ISO 10993-1:2003 - Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
- IEC 60601-1 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-2-33 - Medical Electrical Equipment - MRI
- 21CFR820 - FDA Medical Device Quality System Regulation
- MDD93/42/EEC - Council Directive Concerning Medical Devices
- SOR/98-282 - Canada Medical Devices Regulations
- NEMA MS-6 - Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance Images
- NEMA MS-8 - Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems
- UL94 - Test for Flammability of Plastic Materials for Parts in Devices and Appliances
- UL544 - UL Standard for Safety Medical and Dental Equipment
- Canadian Medical Device License number 72002
Our continuing commitment to quality is an ongoing process to design and manufacture the very best MRI coils. That is our promise to you.