Implantica Renews ISO 13485 and MDSAP Certifications
Medical device company Implantica has successfully renewed its ISO 13485 quality management system and MDSAP certifications following recertification audits by BSI.
Medical device manufacturer Implantica AG has successfully completed its recertification audit program, leading to renewed ISO 13485 Quality Management System (QMS) and Medical Device Single Audit Program (MDSAP) certificates for its Implantica CE Reflux Ltd. subsidiary. The certifications were issued by notified body BSI.
The ISO 13485 recertification confirms Implantica's compliance with the international standard for the design, development, and distribution of medical devices. The MDSAP recertification indicates that the company's QMS meets the requirements of multiple regulatory authorities, facilitating market access.
Implantica stated that these recertifications provide a foundation for the commercial success of its CE-marked product, RefluxStop™. This implant treats the cause of acid reflux and is positioned by the company as a potential new standard of care. The company highlighted that the process reaffirms its commitment to high regulatory compliance and patient safety standards.
Implantica is listed on Nasdaq First North Premier Growth Market in Stockholm. Its product RefluxStop™ is currently available in several European markets, including Germany, the United Kingdom, Switzerland, Spain, Italy, France, Austria, Sweden, and Norway.