October, 2021 Continued from previous page
ment, manufacturing of PCBAs and various mechanics, box build and complex systems integration, distribution, and reverse logis- tics services. Certifications include ISO-9001, ISO-
14001, ISO-13485, IATF-16949, ISO-45001, CTPAT, UL508A, daily quality management, Kaizen and Lean Six Sigma. Scanfil also ad- heres to many country regulations such as MDR, IVDR (EU), QSR (USA), MSA (Japan), and South Korea GMP. “Behind everything is the standardiza-
tion of processes and that’s what makes the difference,” says Steve Creutz, managing di- rector for Scanfil Åtvidaberg, Sweden. “Built into every product, no
matter what it is, is a well-devel- oped standardization of manufac- turing processes that are adhered to by every employee in every Scanfil facility. These processes have been tested and proven over the years, aligned with stringent regulatory requirements, and give consistent results 100 percent of the time. They are known and im- plemented by every employee, which enables employees to be nimble and quickly adapt to dif- ferent products, circumstances, assembly challenges, testing, and customer specifications, and they have become part of the Scanfil culture.” “Scanfil has perfected the
ability to integrate its manufac- turing knowledge and its way of producing products with the spe- cialized and demanding highly- regulated and defined require- ments for medical products and technology,” says Mats Lindblad, director for global quality for Scanfil. “One auditor highlighted Scanfil’s way of utilizing highly modern production methods while complying with high regu- latory demands without compro- mising either.”
Tailored Lifecycle Services Another differentiator is the
à la carte menu of complete life- cycle services provided to each customer, no matter the size of the company, where the compa- ny’s located, where they are con- ducting business, or their stage in the product life cycle. Services range from product
design, new product introduction, industrialization, supply chain management, material handling, electronics and mechanical capa- bilities, manufacturing, quality control, final integration, testing, and distribution all the way to the end market. Scanfil NPI/valida- tion of production processes can be seamlessly integrated with the customer’s design transfer and authority approval activities. Scanfil’s design-driven man-
ufacturing approach, vertically integrated production, and com- prehensive supply chain are ad- vantageous from R&D, to manu- facturing, to logistics. SMART tools and systems, such as material handling au-
Standardized processes have helped Scanfil to earn and retain regulatory compliance.
www.us-tech.com Scanfil Supports Medtech from R&D to Market
tomation, autonomous intelligent vehicles (AVIs), cobots (collaborative robots) that assist human operators or other machines in more static and repetitive tasks, big data analytics, manufacturing execution software (MES) and manufacturing internet of things (IOT), and robotic process automation (RPA) that auto- mates and digitizes manual and routine work, are employed. Electronic Device History Record
(eDHR) functionalities fulfill the highest re- quirements of medical device manufacturing by collecting real-time data from production. The system ensures that the right material is used and that all operations are carried out Continued on page 23
Page 19
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