• Kits, Packaging Configurations, And Unit Of Use – A UDI Primer

    I often receive questions to clarify the difference among kits, packaging configurations, and unit of use, and these questions usually inquire about labels or entering data into GUDID. This article answers these questions in simple terms, without citing the regulations, and provides the “mental models” you need to distinguish among the cases and develop a compliant approach.

  • Are You Using Internal Quality Audits Effectively?

    One of the most powerful tools in the quality management toolbox is the internal quality audit. Unfortunately, it often is underutilized or misapplied. The result is that management does not obtain the information necessary to help ensure an effective quality management system (QMS), and may be unprepared for an FDA inspection or a Notified Body audit.

  • An Introduction To International Medical Device Standards

    One common source of misunderstanding in the medical device industry is the method the various national regulatory systems use to identify standards. This article explains the method, starting with standards from the International Organization for Standardization (ISO) adopted and recognized in various regulatory systems. The article uses ISO 13485:2003 and ISO 14971:2007 as illustrations.

  • FDA Inspections And UDI — What To Expect And How To Prepare

    The FDA has not provided specific information about unique device identification (UDI) related activities as part of inspections. In particular, the agency has not updated the Quality System Inspection Technique (QSIT) or issued a Compliance Program Guidance Manual (CPGM). However, it is clear that inspections will include UDI related activities, since they are now part of the regulatory requirements.

  • Updating Your Quality Management System (QMS) For UDI

    The Unique Device Identification (UDI) rule touches just about all parts of the FDA regulations for medical device makers. These are called conforming amendments, because they make the other parts conform to the concepts of the UDI rule. For example, complaints (820.198) and medical device reports (MDRs) (Part 803) need to include the UDI.

  • Populating The UDI Database – A Look At GUDID

    A fundamental purpose of unique device identification (UDI) is to allow users to learn specific device characteristics. The manufacturer puts a device identifier (DI) on the device label that corresponds to a DI record the manufacturer loaded into a database. Anybody with the DI can enter it into the database and retrieve the public information from the DI record that identifies the device.

  • A Guide To Device, Label, And Package Requirements Of The UDI Rule

    On the surface, unique device identification (UDI) is a simple concept. Put the device identifier (DI) on the device label in machine‑readable form. Include the production identifiers (PI) that you have selected, and make sure they are both machine‑readable and human‑readable.

  • Understanding The UDI Rule – A Guide For Medical Device Manufacturers

    The FDA’s UDI (unique device identification) final rule has arrived, and medical device manufacturers are working on their implementation strategies. The first compliance date — for Class III devices produced after September 24, 2014 — passed last month, and additional deadlines are coming up quickly. This article provides an introduction to important UDI concepts and explains the steps manufacturers should be taking to get moving on on UDI compliance. 

Dan O'Leary, President, Ombu Enterprises

Dan O'Leary

Dan O'Leary is president of Ombu Enterprises, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. He has more than 30 years’ experience in quality, operations, and program management in regulated industries including medical devices, aviation, defense, and clinical labs. He has a master’s degree in mathematics; is an ASQ (American Society for Quality) certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in resource management.