American Scientific Resources (ASR) has reported that it is officially an approved manufacturer of medical devices under the International Organization for Standardization (ISO), a developer and publisher of international business standards.
ASR was also an FDA approved manufacturer of various medical devices operating under the ISO 13485 Directive of Quality Systems Manual and Good Manufacturing Practices.
Reportedly, TUV SUD has conducted an ISO inspection for the company, which included implementing a complete traceability and management accountability function in all aspects for a medical device manufacturer and an audit for a CE mark submission.
ASR said that abiding by ISO standards ensures that products contain the desirable characteristics including reliability, safety, efficiency, eco-friendly and affordability.
ASR CEO and chairman Christopher Tirotta said that another exciting company milestone has been achieved by successfully passing the world’s definitive business standardised system.