October 2, 2009
Med Device Firm Earns CE, ISO Approvals
By Matthew L. Brown
Medical device firm Solace Therapeutics Inc. has received the CE mark for one of its devices and ISO certification for its Framingham facility.
The CE mark is a consumer safety designation in Europe and allows the company to move forward with clinical development of its Solace Intravesical System there. The system is a non-surgical bladder control device.
The ISO 13485:2003 certification is a quality management systems designation specifically for medical device manufacturers.
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