Solos Endoscopy has entered into an agreement with Expert Resource to finalize ISO 13485 certification and CE Mark initiative for its endoscopic instruments.
Under the agreement, Expert Resource will provide comprehensive consulting, training and document preparation for Solos Endoscopy to create a quality management system that meets the requirements of the ISO 13485 standard.
The ISO 13485 standard certification enables Solos’ endoscopic instruments to receive CE mark.
Previously, Solos has retained Expert Resource and completed Phase I of IV of its requirements for its ISO 13485 QMS initiative.
Expert Resource is an international consulting and training firm which helps medical device and medical laboratory companies implement ISO 13485, ISO 15189, ISO 14971, or GMP quality systems, obtain the CE Mark, submit FDA 510(k) applications, assist with clinical trials.