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.
