Regulation in medical products bring challenges to EMS companies

Medical technology and device companies have unique requirements when selecting a manufacturing partner.

Medical technology and device companies have unique requirements when selecting a manufacturing partner. ISO-13485 medical device certification is a must, but it’s only a baseline. It takes years for a contract manufacturer to develop accurate and precise processes, establish a network of suppliers for high-quality components, and have the knowledge, resources, and experience to ensure that products meet individual country and worldwide specifications and regulations. Considerations for selection include location, manufacturing capabilities, the breadth of services, quality, and a trustworthy team.

“Scanfil has perfected the ability to integrate its manufacturing knowledge and its way of producing products with the specialized and demanding highly-regulated and defined requirements 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 regulatory demands without compromising either.”

One of Scanfil’s medical customers is Jolife. Scanfil’s journey with Jolife, a part of Stryker, started more than 20 years ago. Back then, Jolife AB was a small start-up company located in Lund, Sweden. The company developed and launched the LUCAS chest compression system, which redefined emergency care and helped save lives. It is also a good example of a long and successful manufacturing partnership.

The LUCAS system is now in its third generation. Sara Lindroth, managing director of Jolife AB, a part of Stryker, says, “During our partnership over the last two decades, we have successfully passed many audits by regulatory authorities and have seen steady growth of sold units on a global market.”

For the past 25 years, Scanfil has served companies developing products for medtech, life science, and environmental measurement and analysis. Scanfil has around 3,200 employees with nine factories worldwide in Europe, North America and Asia. These factories offer engineering, development, manufacturing of PCBAs and various mechanics, box build and complex systems integration, distribution, and reverse logistics services.

Read the whole article by Michael Skinner, Editor US Tech

MedTech article about Scanfil in USTech