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All, A Big Trend I notice in the Pharmaceutical & Biopharmaceutical Industry is the growing importance of Data Integrity. What is the consensus of the group of the focus of the FDA & other Regulatory agencies on Data Integrity for Medical Dev...

ISO 14971 is under systematic review. This means that Nationals Committees will vote if the standard will be reconfirmed, revised, or withdrawn. If you have any comments the use of the standard and suggestions for modifications, I would urge to parti...

With the changes in ISO13485 authorizing notified bodies to perform unannounced audits at what you have identified, or the NB believes, to be critical elements in the value chain. What a boon to NB’s they get to charge us for the cost of audits at ou...

The acronym DMAIC stands for: 1) Define, 2) Measure, 3) Analyze, 4) Improve, and 5) Control. I am suggesting the use of these 5 steps to target implementation of process risk controls to prevent complaints.Step 1 (Define) - Identify the most likely c...

A colleague asked me today about a possible conflict between the date that should be used for Block B4 of the MedWatch 3500A form. Per the 3500A Form Instructions, Block B4 should be date the initial reporter provided the information about the event ...

Last night I published a blog (http://www.medicaldeviceacademy.com/blog) about how to write a template for the device description section of a 510(k) submission (i.e., Section 11). As with all things I do, I have three basic tactics:use a harmonized ...

The number of medical apps grows by the day, also the capability of such apps continues to improve. With the internet being effectively border-less, is it inevitable, that the regulatory bodies will not be able to control or regulate a significant po...

source: https://www.linkedin.com/groups/2070960/2070960-6065525571830505474

Risk management is one of the hottest (and at times, most confusing) topics in the medical device industry today. ISO 14971, the current risk management standard for med devices, provides a thorough explanation of relevant terms and defines the risk ...

In addition to inhouse production and OEM outsourcing, there are always items that make more sense to just purchase and sell as 3rd party items to convenience customers.When should 3rd party items be regulated according to a Quality Management System...