Have you ever had the misfortune of ordering an item over the Internet, having it shipped to your home, and upon opening the box, finding the item badly damaged? Let’s face it ladies and gentlemen, regardless of the carrier, USPS, UPS, or Fedex, products take a beating during the rigors of “routine shipping and handling.” In this edition of Devine Guidance (DG), Dr. D will provide guidance for 21 CFR, Part 820, Subpart – L (Handling, Storage, Distribution, and Installation), specifically (820.140 –…
Labeling and what constitutes being a label can be confusing for device manufacturers. This week, Devine Guidance explains 21 CFR, Part 820 – Subpart – K, Labeling and Packaging Control, specifically 820.120 (Device Labeling) and 820.130 (Device Packaging). There are three takeaways: The accuracy of device labeling is mission-critical for device manufacturers; product packaging and labeling need to be properly validated, including distribution cycles, storage conditions, and useable shelf life; and famil…
In this edition of Devine Guidance , Dr. D provides guidance for 21 CFR, Part 820 – Subpart – J, Corrective and Preventive Action (CAPA), specifically (820.100). A strong CAPA system will allow organizations to track quality problems to closure. CAPA is not rocket science: you identify problems and you fix problems.
In this edition of Devine Guidance (DG), the doctor will provide guidance for 21 CFR, Part 820 – Subpart – I, Nonconforming Product, specifically (820.90). The key takeaways for this week are: sticking to procedures; understanding the importance and elements of effective control of nonconforming product; refraining from the UAI disposition; reworking to approved specifications; and maintaining and updating accurate DHRs.
In this week’s edition of Devine Guidance (DG), the doctor will provide guidance for 21 CFR, Part 820 – Subpart – H, Acceptance Activities, and specifically (820.86), Acceptance Status. There is really just one takeaway from this week: ensure all devices are properly labeled with the appropriate acceptance status.
In this week’s edition of Devine Guidance , the doctor provides guidance for 21 CFR, Part 820 – Subpart – H, Acceptance Activities, and specifically (820.80), receiving, in-process, and finished device acceptance. Selecting suppliers capable of supporting an effective SSDP, employing statistical tools when performing in-process acceptance activities, completing final acceptance activities before finished devices can be released for distribution, and collecting and placing appropriate information into rec…
Process validation is a mission-critical activity. Medical device manufacturers must ensure all processes are either verified or validated. This week’s Devine Guidance discusses compliance with section 820.75—process validation.
The evaluation and management of risk throughout the product life cycle is the single most important concept in the regulation of medical devices. Yet it is difficult to define precisely what “risk” means or how to assess it in an industry where some 115,000 devices are produced by thousands of manufacturers, employing a dizzying array of technologies destined for use in varying health settings for every imaginable indication. So who determines the risk, and where do problems typically arise?
Inspection, measuring, and test equipment form a significant part of the quality-system foundation for successful medical device manufacturers. Device manufacturers need effective tools to gage adherence to approved product specifications; and the vehicle employed for doing so is the performance of acceptance activities utilizing inspection, measuring, and test equipment.
In this week’s edition of Devine Guidance , Dr. D will complete (it’s about time!) the review of section 820.70 of the Quality System Regulation (QSR), and focus on subsection (h) manufacturing material, and (i) automated processes.