Imagemagick

Install Imagemagick, a powerful command line image tool, with Homebrew in my iMac.
1. install XQuartz first, download file from http://xquartz.macosforge.org
2. brew install imagemagick --with-x11
3. convert logo: logo.gif; display logo.gif

Pass FDA 's Tests

FDA websites, specially Center for Devices and Radiological Health (CDRH) is certain to the first study source for medical device industry and research. After study carefully of 21 CFR part medical device, cosmetics and drug, CDRH learn materials, I have passed serveral important tests.

Factors to consider before a innovative idea to real market success in medical device.

It is easy to find ideas that appear to have promising business potential, but ultimately very few have the potential for real market success. Many factors need considered before we determine if a idea will have real impact. Serveral considerations which may increase the chances of success in medical device development are listed:

1. A new medical device must solve a real clinical problem or substantially lowers the cost of treatment and decreases mortality or serious morbidity relative to the standard of care.
2. Understand how large the potential market (size and growth) for the new product is, and how ready the clinical users will be to adopt it.
3. Learn intellectual property. Obtain protection of own patent and avoid infrigement of other's patents.
4. Conduct clinical trials as early as possible if necessary.
5. Plan the regulatory strategy early. The better you understand the regulatory framework, the greater your chance of success.
6. Understand the reimbursement landscape.
   
   

Online Medical Devices Registration: Licensale.com

Medical device industry is highly regulated. Regulatory affairs of medical devices are complex and time-consuming procedures. Just find a unique, cloud-based, global regulatory system LICENSALE.COM from Arazy Group that simplifies international regulatory affairs.

顾客满意-ISO 9001与ISO 13485的区别

对比ISO 9001质量管理体系，ISO 13485医疗器械质量管理体系标准里没有“顾客满意”的要求，代之以“满足顾客要求”。标准中解释：“顾客满意”和“顾客感知度”在法规中作为要求来实施太过于主观。以“满足顾客要求”作为对质量管理体系绩效的测量，与ISO 13485反应当前监管法规和促进世界医疗器械监管法规协调的目标相一致。

所谓“良药苦口”，医疗器械在保证安全、有效的前提下，有时不得不对产品使用的舒适性作出折中甚至舍弃一致降低了顾客满意度。同时，一味地追求顾客满意也会对医疗器械产品的研发、制造产生不利的影响。

虽然现在的标准中未要求＂顾客满意＂，但个人认为在保证医疗器械产品安全、有效的前提下，顾客的使用舒适性应在产品研发阶段给予充分考虑。同时，对顾客使用舒适性的反馈信息的深入分析结果是下一步产品开发和改进的重要的参考。通过考虑结和最新科技成果、仔细分析和评估风险/受益及应用人因工程学原理等，提供产品的使用舒适性，才能更好的开发出顾客满意度高的、具有强大市场竞争力的产品。

Standards of Antimicrobial and Anti-biofilm Assay

In the academic research, different labs and groups have their protocols for evaluating antimicrobial/antibiofilm properties of modified surfaces/materials and antimicrobial agents. In the industrial R&D, adopting international standards is more reliable and trusty. Below is the summary of main standards for antimicrobial/antibiofilm assay used in medical device industry:

• Antimicrobial Effectiveness Tests in United States Pharmacopeia (USP) Chapter 51.
• Zone of Inhibition, MIC, MBC:  refer to standards from the Clinical and Laboratory Standards Institute (CLSI).
• ISO 22196, Measurement of Antibacterial Activity on Plastics and Other non-Porous Surfaces. (based on JIS Z 2801)
• ISO 20743, Determination of Antibacterial Activity of Textile Products.
• ASTM E2149, Standard Test Method for Determining the Antimicrobial Activity of Antimicrobial Agents Under Dynamic Contact Conditions.
• ASTM E2180, Standard Test Method for Determining the Activity of Incorporated Antimicrobial Agent(s) in Polymeric or Hydrophobic Materials.
• ASTM E2315, Standard Guide for Assessment of Antimicrobial Activity Using a Time-Kill Procedure.
• ASTM E1054, Standard Test Methods for Evaluation of Inactivators of Antimicrobial Agents.
• ASTM E1326 Standard Guide for Evaluating Nonconventional Microbiological Tests Used for Enumerating Bacteri.
• JIS (Japan Industrial Standard) Z 2801, Antimicrobial products–Test for Antimicrobial Activity and Efficacy.
• EN 1276, Chemical Disinfectants Bactericidal Activity Testing.
• EN 1040, Basic Bactericidal Activity of Chemical Disinfectant. 
• ASTM E2647, Standard Test Method for Quantification of Pseudomonas aeruginosa Biofilm Grown Using Drip Flow Biofilm Reactor with Low Shear and Continuous Flow.
• ASTM E2196, Standard Test Method for Quantification of Pseudomonas aeruginosa Biofilm Grown with Medium Shear and Continuous Flow Using Rotating Disk Reactor.
• ASTM E2562, Standard Test Method for Quantification of Pseudomonas aeruginosa Biofilm Grown with High Shear and Continuous Flow using CDC Biofilm Reactor.
• Guidances and SOPs by the European Committee on Antimicrobial Susceptibility Testing (EUCAST).