Quality Assurance: ISO13485 certification

ORA is certified ISO13485 Medical Devices

PET Synthesizer NEPTIS ISO logo 02In 2009, the NEPTIS project was started based on the long experience in radiotracers production in GMP environment and became the combination of a multi-purpose PET synthesizer and an advanced software system meeting the latest GMP requirements.

This new combination offered then the capability of creating an unlimited number of individualized radiotracer synthesis applications.

Gradually, NEPTIS synthesizers were approved worldwide by many drug agencies.

In order to increase customer confidence and meet the strictest regulations, ORA developed and implemented a Quality Management System in order to document the company’s best business practices, better satisfy the requirements and expectations of its customers and improve the overall management of the company.

This Quality Management System of ORA, today meets the requirements of the international standard ISO 13485:2003. This system addresses the design, development, production, installation and servicing of the company’s products.

Click here to download the ISO13485 certificate of ORA.

Our Company Quality Policy

ORA will consistently provide products and services that meet or exceed the requirements and expectations of our customers. We will actively pursue ever improving quality through programs that enable each employee to do their job right the first time and every time.

ORA will consistently provide a quality management system in line with ISO 13485 requirements and with the MHLW Ministerial Ordinance N°169 (Japanese regulatory requirements).