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All Class II devices marketed in the USA must be labeled with UDI bar codes by September 24, 2016--just 19 days away. This announcement summarizes the basic steps for UDI implementation.Step 1: Make a list of all the devices requiring a UDI. A separa...
Even before the FDA’s final rule was published for UDI in 2013, companies were implementing UDI systems. What has not been clear is how the FDA would enforce UDI compliance. The most logical methods of enforcing UDI compliance are:1. require a draft ...
I would appreciate some input as to what other Companies have done in similar situations. An Authority has asked for the ISO 13485 Audit report to be sent in as a part of the Companies Authorization. To start with the Certificate was sent, then confi...
The most common way to answer this question is with a question.How long is a review supposed to take? orHow long does a review actually take?Most people want to know the answer to the second question, and they want real data to back it up. Therefore,...
In addition to the qualification requirements for clinical evaluators (prescribed in section 6.4 of MEDDEV 2.7.1 rev 4 which was published June 29, 2016), each of the evaluators must provide a detailed “Declaration of Interest” detailing all relevant...
At the beginning of 2015 I wrote a blog about 510(k) project management (http://medicaldeviceacademy.com/510k-project-management-an-inside-look-at-our-process/) and I recorded a webinar on the topic (http://medicaldeviceacademy.com/510k-project-manag...
Hello all,Maybe this is a basic question for many of you, but I have a doubt regarding the Standards that should be declared on the Declaration of Conformity according with the MDD 93/42/EEC.The Situation is, the harmonized standard EN 60601-1:2006/A...
Medical devices sold in Europe carry the CE Mark. Does anyone have a list of non-EU countries who also require the CE Mark? (e.g. the Saudi regulatory body will accept the mark)Thanks for your feedback!source: https://www.linkedin.com/groups/78665/78...
A client of mine recently asked me to help them plan a clinical study for a low-risk medical device. The company is located in the USA and they intend to launch the product is the USA first. At first I was shocked, because there was no clinical study...
Hello All,I came across situation where I am not sure what is optimal and really required. We have received IEC 60601-2-47 (ambulatory ECG recorder) and IEC 60601-1-2 (EMC) test reports from one of the well known testlabs. Now, Testlab has included c...
