Risk Management

In the design control requirements, the FDA refers to Risk Analysis. This is such a critical aspect of manufacturing medical devices, ISO created a standard for just this subject – ISO 14971 ‘Application of Risk Management to Medical Devices’. ISO 14971 identifies Risk Management as “The systematic application of management policies, procedures and practices to…

Unique Device Identification

Section 226 of the FDA Amendments Act (FDAAA) of 2007 and Section 614 of the FDA Safety and Innovation Act (FDASIA) of 2012 amended the Federal Food, Drug and Cosmetic Act to add section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices along with implementation timeframes for…

Design Input Part 9

Once you have a device with a 510(k) clearance, you can start production.  As your product gets into the marketplace, and feedback starts coming in, you may decide that changes are needed to make it a “better” product.  While you are allowed to continually improve your product, some changes might have bigger impact than others. …

Dr. Sandle on Cleanrooms & Contamination

For pharmaceutical manufacturers, hospitals and other facilities that contain cleanroom technology, the risk of contamination can be avoided by implementing proper environmental controls. These controls range from efficient cleanroom design to implementing gowning procedures. A full, detailed article on what you can do at your facility to maintain workplace safety and prevent contamination is available…

Design Input Part 8

The Design History File is the final component of the design control process.  The FDA defines a Design History File (DHF) as “a compilation of records which describes the design history of a finished device”.  While there are not any specific requirements in either ISO 9001 or ISO 13485, a DHF is required by the…

Design Input Part 7

According to the FDA, you are required to have controls in place that address design changes.  The verbiage in 820.30(i) states that “each manufacturer shall establish and maintain procedures for the identification, documentation, validation or – where appropriate – verification, review and approval of design changes before their implementation.”  The purpose of documenting Design Change…

Design Input Part 6

Design Transfer may be one of the most important transitions in the design process, as it is the introduction of a design to production.  Since this is such an integral process in the early part of product development, it must be well executed.  The FDA requires the manufacturer to complete the following steps in order…

Safety Risk: Duodenoscope Reprocessing

An article published by the Association for the Advancement of Medical Instrumentation (AAMI) on May 20, 2015 acknowledges the safety risk associated with duodenoscope reprocessing. Multidrug-resistant infections associated with reprocessed duodenoscopes has impacted more than one hundred patients, with the risk of involving even more. On May 15, the majority of members of the Gastroenterology…