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Responsiveness, commitment, and collaboration— it’s all intrinsic to every partnership we make. From delivering ART solutions designed to help optimize clinic workflows to providing a tailored service experience that exceeds your expectations, we’re working with you to support healthy futures— from retrieval to realization.
Quality is a total company effort
At FUJIFILM Irvine Scientific, we realize that every person contributes to the success of our products and the outcomes they provide. Since 1987, our ART media has been made in a centralized campus in California where each department can easily collaborate to deliver high quality products. Hear from each department about how they are ALL IN on Quality.
Material Handling
Sourcing, qualifying and receiving is the first critical step – we make sure that raw materials are correct, of high quality, and handled appropriately before they are used for production.
Manufacturing
Quality is the top priority of the production team – that means quality equipment, safety standards, and quality procedures that produce exceptional products.
Quality Control
Quality Control verifies that the products and the environment in which we make products meet global standards.
Quality Assurance
A complete and thorough review of the process from manufacturing to QC testing – we consistently check all areas to ensure everything is correct and the product is truly ready for our customers.
Customer Service
Quality doesn’t stop with the product – quality service is our goal, and it starts with accurate and on-time deliveries.
Shipping
Our products make a difference in patients’ lives – we understand the need for secure temperature controlled packing and rapid delivery to our customers within specification.
Marketing
Marketing is the 'voice of customer' within the company – we drive customer expectations internally to deliver high quality, innovative products to you.
Sales
The sales team brings critical customer feedback to the company to make sure customer needs and requirements are being met - on service, on performance, and quality.
Technical Support
We strive to be the cornerstone of quality and service – and that’s where Technical Support comes in. Managing customer inquiries quickly with high satisfaction is a critical aspect of our quality system.
At FUJIFILM Irvine Scientific we are
What does a commitment to Quality look like on an annual basis?
- Ensuring our raw materials and suppliers are top quality
- 20+ audits of raw material suppliers
- 35,000 raw material and products tests
- Ensuring sure our products are safe and effective
- 1,800 batches of media manufactured
- Over 50,000 environmental monitoring tests
- Over 1,000 Mouse Embryo Assays and MEGA tests
- Ensuring we are meeting our customers’ and regulators’ expectations
- 30+ audits from customers and regulatory agencies
- 30 man days of internal audits
- Compliance with ISO13485.2016 and MDSAP
“ALL IN on quality means the entire organization, from colleagues cleaning our facilities, to those packing our shipments all the way up to the C-suite, are engaged, involved and committed to doing the right thing the first time.”
- Marlin Frechette, Chief Quality Officer
As worldwide cell culture media providers, FUJIFILM Irvine Scientific is regulated and adheres to both FDA and ISO regulations. These regulations ensure that every product manufactured, packaged and sold by FUJIFILM Irvine Scientific performs according to the claims and the methods, facilities, and controls in place within our organization are sufficient to ensure safety and efficacy of each product.
To maintain our quality systems, we have set to stringent policies and standard operating procedures from the initial evaluation and qualification of suppliers to our quality testing for raw materials and finished product. Additionally, we provide extensive regulatory support and evaluation to ensure qualification and compliance of products sold to IVF clinics globally. Our quality and regulatory systems are compliant with:
- Good Manufacturing Practices (cGMP)
- Current Guidelines for Manufacture of In Vitro Diagnostic products
- FDA Cleared Class II Medical Devices
- 21 CFR 820 Quality Systems Regulations (US FDA)
- European Medical Devices Directive (93/42/EEC); CE Marked Devices
- European Medical Device Regulation (2017/745) Compliant
- ISO 13485:2016 Certified
- Medical Device Single Audit Program (MDSAP) Certified
