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FDA Software Validations Are Tied to Manufacturer’s Implementation | iBASEtA very common misunderstanding of this validation requirement is that FDA compliance can be met by having their software vendors “validate” the software they are selling.sourc...
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...
Dear fellow professional,I would like to ask your opinion on what follow.Thank you to all the contributors.According to MEDDEV 2.1/1 and Directive 93/42/CE, the intended use of the accessory must be such as to enable a device to be used in accordance...
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 ...
The most common nonconformity identified by reviewers of a CE Marking submission is an inadequate or missing clinical evaluation report (CER). Preparing a CER is time consuming, but if you have a good protocol and procedure the process does not need ...
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...
