Solos Endoscopy, a Healthcare instrument company, has signed an agreement with Expert Resource (ER) to provide consulting services in support of the company's ISO 13485 quality management system (QMS) initiative.
As per the agreement, Expert Resource expects to 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.
Compliance with ISO 13485 is a step in obtaining the CE mark and the permission to sell medical devices in the European Union.
Bob Segersten, president of Solos Endoscopy, said: “It has been our goal to expand our markets into Canada and the European Union. Expanding into the EU and Canada presents enormous sales opportunities for Solos Endoscopy. We are pleased to be working with Expert Resource to provide the specialized assistance we need in developing our management and manufacturing systems in order to ultimately obtain the CE Mark.”
Expert Resource is an international consulting and training firm specialising in business improvement initiatives. ER 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, and assist with clinical trials.
Solos Endoscopy develops and markets instruments for the screening, diagnosis, treatment and management of medical conditions.