Third Parties of Biological Evaluation and Biocompatibility Testing of Medical Devices

The biocompability of medical device is the basic requirement to ensure safety of medical devices. Biocompatibility testing shall be conducted in compliance with Principles of Good Laboratory Practice (GLP) and/or ISO/IEC 17025. Before any test, check related administration if test results of the third-party is accepted.

Some third parties which can carry out biocompatibility testing according to ISO 10993 are listed as below:

• TUV-SUD.
• UL.
• Toxikon.
• Pacific Biolabs.
• Nelson Labs.
• American Preclinical Services.
• Cytox.
• NAMSA
• Medical Engineering Technologies Ltd.
• Shanghai Biomaterial Research and Test Center, cerificated by CFDA.
• WuXi Apptec, cerificated by CFDA.
• GLR Labs.
• RCC Labs.
• PWG.

rsync - a tool for synchronizing files

Rsync is a powerful Unix-type command line tool. I use it to backup my data. The rsync in Mac OX S is version 2.69. Today I upgrade it to version 3.09.

1. Download rsync source file rsync-3.0.9.tar.gz, extract and install:

$ tar xzvf rsync-3.0.9.tar.gz

$ cd rsync-3.0.9

$ ./configure

$ make 

$ sudo make install

It install rsync to /usr/local/bin, so need make a symbolic link:

$ sudo mv /usr/bin/rsync rsync.old (change old rsync name)

$ sudo ln -s /usr/local/bin/rsync /usr/bin/rsync

The New Product Development Decision Process

Philip Kotler's classic book "Marketing Management" gives a flow chart of the new product development decision process from idea generation to commercialization. This is a important reference for the product development.

International Standards on Sterilization of Medical Devices

Both the Association for the Advancement of Medical Instrumentation (AAMI) and the International Organization for Standardization (ISO) have developed standards and viable validation guidelines for sterilization of medical devices. These standards often prepared in response to regulatory requirements related to good manufacturing practices and quality assurance.

Except ISO 10993-7 Biological Evaluation of Medical Devices-Ethylene Oxide Sterilization Residuals, other main standards on sterilization of medical devices can be learned in the ISO website. FDA also issued a guidance document.

Fortune Cookie

Fortune cookie is an interesting program in Unix-like system. I used it when install Slackware Linux in my PC more than 15 years ago. Today I re-install it in my iMac and used with cowsay and lolcat.

1. Install Xcode command line tools. (its size is much smaller than Xcode)
2. Install Homebrew
3. terminal--->brew install fortune-mod cowsay
4. Add rainbow effect with lolcat. Install it with gem.

More fancy staffs can be added to .profile to change the cow file randomly when you start terminal.

COWDIR=/usr/local/Cellar/cowsay/3.03/share/cows/
COWNUM=$[$[RANDOM%$(ls $COWDIR | wc -l)]+1]
COWFILE=$(ls $COWDIR | sed -n ''$COWNUM'p')
fortune | cowsay -f $COWFILE| lolcat

Lyx

Lyx is a documental processor that combines, you can say compromise too :), the power and flexibility of Tex/Latex with the ease of use of a graphical interface. It encourages an approach to writing based on the structure of your documents (What is you see is what you mean) and not simply their appearance (What is you see is what you get).

Latex which is typesetting engine for Lyx can obtain high quality, structured, and elegant documents that cannot easily obtained with Microsoft Word. After many years of using Latex, I feel the thinking flow when you writing document seems to be different from Word. If you have a basic knowledge in Tex/Latex, it is very easy to familar with Lyx. I use it from version 1.3 to 2.06 now. It is better and easier for scientist and engineer (maybe except math geek) to use than Latex.

Today I install Lyx in my iMac after I intall MacTex.