Supply Chain and Adv Mfg 2023
Supply Chain and Adv Mfg 2023
From The Editor's Desk

Join J&J, Pfizer and FDA at the Supply Chain Summit and Advanced Manufacturing Conference

By MedTech Intelligence Staff

Supply chain challenges and the move to advanced manufacturing are two key issues affecting the Medtech industry. On November 7-9, MedTech Intelligence will be hosting the MedTech Advanced Manufacturing Conference and Supply Chain Summit, in partnership with Axendia, Inc. The two events will run back-to-back with registration options available for each program as well as a discounted rate for professionals who would like to attend both programs.

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AVEIR DR
AVEIR DR

FDA Approves Abbott’s Dual Chamber Leadless Pacemaker

By MedTech Intelligence Staff

Results from the AVEIR DR i2i Investigational Device Exemption (IDE) study through three-months post-implant showed a 98.3% implant success rate for physicians and more than 97% of people had a successful atrio-ventricular synchrony, so that the upper and lower chamber were beating normally, despite different types of underlying slow heart rhythms.

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Gabe Siftar and Matt Nowell
Gabe Siftar and Matt Nowell

Managing Software Vulnerabilities: How to Utilize ISA/IEC 62443 and Software Bills of Materials

By Gabe Siftar, Matt Nowell

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.

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