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OriGen Earns New ISO 13485:2016 Certification (MDSAP Program)

News & Insights

AUSTIN, Texas, January 11, 2019 — Global medical device manufacturer, OriGen Biomedical, Inc. announced today the award of ISO 13485:2016 Certification and MDSAP Certification following the successful completion of its Quality Management System (QMS) audit.

Audited by LNE/G-MED; one of the leading global certification organizations, OriGen’s new certification places a greater emphasis on the excellence of its Quality Management System throughout the supply chain and product lifecycle, as well as device usability and post-market surveillance requirements. In the closely regulated and highly competitive industry of medical device manufacturing, adhering to the latest ISO certification standard is essential to delivering innovative, high-quality medical products to users around the globe.

“We are all proud to earn certification to ISO 13485:2016 and MDSAP Certification for product manufacturing.” said Richard Martin, President. “This shows the commitment of all OriGen employees to continuous improvement and compliance with the highest regulatory standards.”

The International Organization for Standardization (ISO) is a non-government entity comprised of academic and industry professionals that certifies that companies are compliant with industry-standard best practices in their production and operations.

As of Jan 01, 2019, Medical device manufacturers are required by Health Canada to certify compliance of their quality systems to the new standard using the MDSAP program in order to remain in compliance. The ISO 13485:2016 standard for quality management systems places an increased emphasis on risk management and also aligns more closely with the FDA’s Quality System Regulations for medical device companies manufacturing or selling products into the United States.

“This shows the commitment of all OriGen employees to continuous improvement and compliance with the highest regulatory standards.” – Richard Martin, President

OriGen Biomedical, Inc

OriGen Biomedical, Inc. is a leading producer of cryopreservation, cell culture, and ECMO respiratory products. Origen’s focus is to produce a range of products to treat respiratory distress, cancer, genetic conditions, and other life threatening diseases. Our products are designed with the patient and user in mind and we strive to maintain excellent customer service to ensure that patient care is the priority.

OriGen Biomedical is a growing, privately-held medical device manufacturer founded in 1997 and headquartered in Austin, Texas. Our engineers have more than 70 years of experience with dozens of different specialty medical devices. Quality is the foundation of all product designs at OriGen, and each product is produced with the intention that it will improve patient health. OriGen is certified annually to ISO 13485 standards, and regularly inspected by the FDA, ISO-certification organizations, and our customers. For more information, visit www.origen.com. Follow-us on LinkedIn at https://www.linkedin.com/company/origen-biomedical/ .