Product quality is our top priority. We design every product with one goal in mind: improving patient health. We understand how important our role is in your daily operations, which is why we prioritize consistently improving our operations to support your changing needs effectively and safely as you develop new therapies. OriGen holds and maintains ISO 13485 and MDSAP certifications and is routinely audited by its certification body, regulatory authorities, and our customers.
Our Quality Policy
We believe that our primary responsibility is to the patients who ultimately receive our product. In order to fulfill this responsibility, we will:
- Ensure our products comply with applicable safety and regulatory requirements.
- Provide products that consistently meet or exceed our published specifications for product quality and performance.
- Provide timely delivery of products and services to meet our customer’s requirements.
- Ensure our personnel are properly trained so they are better able to serve our customers.
- Maintain the effectiveness of the Quality Management System.
All these responsibilities are shared by each individual employee of OriGen Biomedical. We will collectively and individually work to fulfill these obligations to the best of our ability.
Regulatory Information
Our commitment to quality is exemplified by our ISO 13485 Certification, ensuring the highest standards in medical device manufacturing. Our products have received marketing clearance from the FDA, are CE-marked, and have gained approval in numerous international markets. For detailed registration information for each device, we invite you to visit the individual product pages. We prioritize regulatory compliance to provide our customers with confidence in the safety and efficacy of our products worldwide.
Our 510(k) Numbers:
- CryoStore Bag 510(k) Number: BK030036
- PermaLife™ Bag 510(k) Number: K021702
- CryoStore Multi-Chamber Bag 510(k) Number: BK180278
LINKS
FDA Website
USA-UDI DATABASE
HEALTH CANADA MDL DATABASE
SYMBOL GLOSSARY
CERTIFICATES
A Message from the Director of QA/RA
As the Director of Quality Assurance and Regulatory Affairs at OriGen Biomedical, I am dedicated to ensuring the highest standards of product quality and regulatory compliance. Our commitment to improving patient health is reflected in our ISO 13485 and MDSAP certifications, demonstrating our adherence to rigorous regulatory requirements. OriGen’s manufacturing facilities in Austin, Texas, uphold strict cleanliness standards, including ISO-class cleanrooms, to ensure product integrity and sterility.
With a robust Quality Management System governing every stage of production, we conduct thorough inspections and testing to maintain safety and efficacy. Our traceability measures enable swift identification and resolution of any quality issues or recalls, while stringent policies for particulate matter control mitigate potential risks. Our post-market surveillance processes allow us to monitor product performance and address any concerns promptly. We are committed to exceeding customer expectations and continuously improving our processes to ensure the well-being of patients worldwide. Thank you for choosing OriGen Biomedical for your needs.
Facilities & Quality Management
Manufacturing Location
OriGen is proud to call Austin, Texas, home to our headquarters and state-of-the-art manufacturing facilities—located at 7000 Burleson Road, Bldg. D, our plant classification as Medical Device Design and Manufacturing demonstrates our commitment to delivering innovative solutions in the cell and gene therapy industry. Since our establishment at this location in March 2010, we have continuously grown and expanded. In 2012, we expanded our site to encompass approximately 45,000 sq. ft. of manufacturing and office space, which includes two cleanrooms.
All of our products are manufactured, warehoused, and shipped from our Burleson facility, allowing us to maintain complete control over the quality and integrity of our products throughout every stage of the process. Our cleanroom facilities adhere to stringent ISO Class 8 and ISO Class 7 standards, with laminar flow hoods meeting ISO Class 5 requirements. To ensure the highest standards of cleanliness and sterility, each cleanroom undergoes quarterly environmental monitoring and annual (re-)qualification to established standards.
Quality Management System
We ourselves on our commitment to quality and excellence in every aspect of our operations. Our dedication to delivering superior products is reflected in our robust Quality Management System (QMS), which governs every stage of the manufacturing process, from product design and development to distribution and customer support.
Our QMS adheres to stringent regulatory requirements and industry standards, ensuring that our cryopreservation and cell culture bags, as well as accessories, meet the highest standards of safety, efficacy, and reliability. Through continuous monitoring, evaluation, and improvement initiatives, we strive to exceed customer expectations and maintain our position as a trusted leader in the field of medical devices for cellular research and therapy.
Post-Market Surveillance
OriGen understands the importance of post-market surveillance in ensuring our products’ ongoing safety and effectiveness. Our commitment to excellence extends beyond manufacturing to include robust post-market surveillance processes that allow us to monitor product performance and address any issues that may arise.
Central to our post-market surveillance efforts is the collection and analysis of customer feedback and complaints. We actively encourage our customers to provide feedback on their experiences with our products, whether positive or negative, through various channels such as surveys, customer support interactions, and online platforms.
Additionally, we have a dedicated system for receiving and managing customer complaints within our QMS, which are thoroughly investigated, documented, and addressed in a timely manner. Complaints are handled per the requirements of the regulatory authority of the country from which they were received. By continuously monitoring customer feedback and complaints, we can identify trends, detect potential safety issues, and implement corrective actions to ensure our customers’ ongoing safety and satisfaction.
QA Processes for Product Integrity
Quality assurance is at the forefront of our manufacturing process. We conduct rigorous inspections of incoming materials to ensure they meet our predetermined specifications before they are incorporated into our final products. Our Quality Assurance Department follows strict sample size inspection protocols based on internal standards and adheres to ISO 2859 / ANSI Z1.4 guidelines.
Throughout the manufacturing process, in-process inspections are performed according to individual product-specific procedures to maintain the highest standards of quality. Final product inspection occurs after products are carefully placed in Tyvek® pouches and final product cartons. To ensure the integrity of our products, pre- and post-sterilization inspections are conducted. Additionally, all of our bag products undergo leak testing by both the bag outline manufacturer and OriGen during our internal manufacturing process, ensuring the reliability and safety of our products every step of the way.
Traceability
Our daily operations center around ensuring the traceability of our products throughout the supply chain. From the moment raw materials are received to the delivery of the final product to our customers, we implement robust tracking measures to trace each product’s journey and maintain complete visibility and control. Our comprehensive traceability protocols include detailed record-keeping, unique product identifiers, GUDID numbers, and electronic tracking systems that capture essential information such as manufacturing dates, lot numbers, and distribution channels.
This approach to traceability allows us to quickly identify and isolate any products that may be affected by quality issues or recalls. In the event of a recall or quality issue, our traceability systems enable us to pinpoint the affected products swiftly, notify relevant stakeholders, and take appropriate corrective actions to mitigate risks and ensure patient safety.
Particulate Matter Control
OriGen has stringent policies and procedures in place for particulate matter control. Particulate matter, whether originating from raw materials, manufacturing processes, or environmental sources, poses potential risks to the efficacy and safety of medical devices. We have implemented comprehensive particulate control measures throughout our manufacturing facilities to address this.
This includes stringent cleanliness protocols to ISO 14644, regular equipment maintenance, and thorough inspection and testing processes to detect and reduce particulate matter at every stage of production. Our quality assurance team also continuously monitors and evaluates our particulate control procedures to ensure compliance with regulatory requirements and industry best practices.
FAQs
What regulatory approvals does OriGen have?
We are ISO 13485 Certified, plus our medical devices have received marketing clearance from the FDA, are CE-marked, and are generally approved in many other markets worldwide. Please see the individual product pages for the registration of each device.
What if I have a problem with a product? How are complaints handled?
If you encounter any issues with an OriGen Biomedical product and wish to file a complaint, we encourage you to do so ASAP. Please contact the OriGen head office or reach out to your dedicated sales representative for assistance. To facilitate our investigation and resolution process, we kindly ask that you retain both the product and its packaging. This will aid us in conducting a thorough analysis of the matter. All complaints will be promptly acknowledged, and you will receive a written or oral response confirming receipt of the product and providing initial findings. Your feedback is invaluable to us as we strive to maintain the highest standards of quality and customer satisfaction.
- Reporting: When a complaint is received, it is promptly reported to our Customer Service (CS) department.
- Notification: CS notifies our Quality Assurance (QA) team about the complaint for further evaluation.
- Assessment: Our Regulatory Affairs (RA) team assesses the complaint to determine if it poses a public health threat or if remedial action is needed to prevent substantial harm.
- Assignment: The QA management assigns the complaint to an appropriate owner for further investigation.
- Investigation: The assigned complaint owner evaluates whether it qualifies as an agency reportable event and conducts a thorough investigation, including a review of the product’s history and failure mode analysis.
- Resolution: If necessary, the complaint owner sends a personalized letter to the customer detailing the findings and any corrective actions taken to address the issue.
Throughout this process, we remain committed to promptly addressing customer concerns and ensuring our products’ safety and satisfaction.
How are CAPAs (Corrective and Preventive Actions) handled?
Throughout the CAPA process, we remain committed to addressing issues promptly, implementing appropriate corrective and preventive actions, and continuously improving our processes to prevent recurrence and enhance product quality and safety.
- Identification and Assignment: CAPAs are initiated for systemic issues or those with potential systemic implications. A group of individuals collectively decides on the CAPA owner, who will be responsible for overseeing the process.
- Coordination: Each CAPA is assigned a dedicated coordinator to facilitate the progression of CAPA actions and ensure timely completion.
- Investigation: The identified problem undergoes a comprehensive investigation, which includes risk assessment, root cause identification, determination of an action plan, and development of an effectiveness plan.
- Implementation: Once the investigation phase is complete, the proposed actions are implemented according to the determined action plan.
- Effectiveness Review: After implementing all actions, the CAPA undergoes an effectiveness review. This review evaluates whether the actions taken have effectively addressed the identified issue or if further measures are necessary to ensure resolution.
Where can I find the Instructions for Use (IFU), Certificate of Analysis (CoA), Certificate of Compliance (CoC) or Safety Data Sheet (SDS) for the product I received?
An IFU, as well as a CoA or CoC, will be in your original shipment box. If these items are misplaced, you can access the IFU, CoA, CoC, and SDS for your OriGen Biomedical® products through the Client Login. If you do not have a current login, you will need to register for an account through that page.