The recently announced “Refuse to Accept Policy” signed into law under section 524B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the FDA more traction to encourage the medical device manufacturing industry to utilize software bills of materials that help to incorporate supply chain security. The ISA/IEC 62443 series of standards defines a secure product lifecycle process that can be adopted by medical device manufacturers to identify and manage the security risks of all external components used within the product.
When it comes to testing, the most significant difference between CSV and CSA is that CSV focuses on a “test everything” approach, while CSA encourages us to use critical thinking to test more effectively. The following article outlines how companies can identify the appropriate degree of testing rigor for risk-based CSA validation to ensure the least burdensome approach.
There are several tactical approaches to design that can help medtech manufacturers inspire patient confidence in their products and ensure proper usage. Following are three ways you can help ease the burden of delivering and receiving quality care through product design.
As 3D printing gains a more prominent place in the manufacture and protoyping of medical devices, advances in technology and materials are expanding indications. We spoke with John Kawola, CEO of Boston Micro Fabrication (BMF), about the move toward micro 3D printing and how this technology is supporting the drive for miniaturization and minimally invasive medical treatments.
In spite of continuing delays to implementation deadlines for EU MDR/IVDR, post-market surveillance requirements are currently in force. Hence, manufacturers need to urgently establish a PMS system to identify potential nonconformances and safeguard users and patients.
Internet-enabled medical technologies have significantly improved the standard of care. They have also introduced a range of challenges for healthcare practitioners, administrators, and patients. The good news is these issues can be mitigated—or, in some cases, eliminated—in the engineering and design phase. Following are five key considerations for manufacturers to help foster connected healthcare’s continued acceleration.
Selecting a strong medical device contract manufacturer is critical to ensure supply chain resiliency, regulatory compliance, and long-term success for a medical device OEM. This article is a guide to the most important questions to ask yourself and your contract manufacturer to help ensure a successful partnership.
Only one third of “The State of ESG in Manufacturing” survey respondents have high confidence in the quality and accuracy of their supply chain data. This article summarizes the risks of poor data, the seven elements that contribute to siloed data, and the associated regulatory risks.
The Food and Drug Omnibus Reform Act (FDORA) authorized FDA to conduct remote device facility inspections. While it will take time for the FDA to take the necessary steps to start performing remote inspections, industry can look to remote regulatory assessments as a potential model.