The U.S. Food and Drug Administration (FDA) plans to use ISO 13485, the international standard for quality management systems for the medical devices sector, as the basis for its quality system legislation.
ISO 13485, published in 2016, is designed to work efficiently and transparently with other management systems. The standard, now in its third edition, received strong support from the FDA, in line with its drive for global convergence of medical device regulatory processes.
NIST guidelines to secure wireless infusion pumps
The National Institute of Standards and Technology (NIST) released the final version of its guidelines to help healthcare organizations block wireless infusion pump cybersecurity threats – unauthorized access of health information to interfere with a pump’s function and drug dosing.
The U.S. Food and Drug Administration (FDA), accelerating efforts to protect the security of connected medical devices with its Medical Device Safety Action Plan (MDSAP), is seeking requirements for manufacturers to build security updates and other protections into products.
NIST guide collaborators include: B. Braun Medical; Baxter; Becton Dickinson; Cisco; Clearwater Compliance; DigiCert; Hospira; Intercede; PFP Cybersecurity; Ramparts; Smiths Medical; Symantec; TDi Technologies; and the Medical Device Innovation, Safety, and Security Consortium.
FDA Clearance for spinal interbody implant
FBC Device’s spinal interbody implant has received its first U.S. Food and Drug Administration (FDA) clearance for its technology – a two-piece interbody fusion device with in-situ adjustment from 9° to 21°, allowing surgeons to simply adjust each patient’s alignment and then lock the two pieces together.
“There is overwhelming evidence that poor spinal alignment is associated with back pain and disability. When we started the company, our goal was to commercialize a series of implants to help surgeons easily restore alignment when performing spinal fusions, so that more of their patients would achieve good or even great results,” says Prof. Finn Christensen, M.D., Ph.D. and founder and CEO of FBC Device.
Two new certifications for Colburn Mfg.
Colburn Mfg. Co. Inc.’s Fridley, Minnesota, facility has been awarded ISO 9001:2015 and ISO 13485:2016 certification from TUV SUD America Inc. The certification demonstrates Colburn Mfg. meets the criteria set by the International Organization for Standards (ISO) and passed the audit, displaying zero nonconformities to the new standards. Colburn had previously been certified under ISO 9001:2008 and ISO 13485: 2003. ISO 9001:2015 applies to Colburn’s quality management and quality assurance systems and reaffirms its commitment to providing components that meet rigorous quality and safety standards and consistently high customer satisfaction.
ISO 13485:2016 applies to Colburn’s credentialing for manufacturing CNC Swiss precision machined parts for the medical industry, certifying a quality management system that meets the standard and furthers the development of risk management and risk-based decision making as a focal point in the medical industry.