Article for the Chinese agency, CCUS (Certification Center International Standards) by Alan Schwartz Recently, we participated in a seminar on United States (US) Food and Drug Administration (FDA) regulations to the Hebei Pharmaceutical Association in Shijianzhuang, the capital city of the Hebei province. This seminar was presented by CCUS, (Chinese Committee for US Standards) a
An FDA Veteran Describes What You Need to Know Before Working With a New Outsourcing Partner Alan Schwartz, Contributing Writer The medical device industry is a very dynamic one, with new companies being set up constantly—bringing either new, unique devices or better designed me-too products to market on a regular basis. Most of these companies
A requirement of ISO13485 (2003) by the Japanese Government authorities for medical devices in Japan. We recently obtained information from our Japanese affiliate concerning ISO13485 and what the future requirements will be by the Japanese Governments for medical device suppliers’ exporters. This information will be very important for any company that is presently exporting medical
An article by Alan Schwartz and George Ye
By: Alan P. Schwartz Should Industry be Accepting? HACCP, what are you talking about? Why would the FDA want to use it for inspecting medical device manufacturers? But why is the FDA now looking to implement a policy that was strictly used for the food industry, for the medical industry? If I am correct, I
GMP vs. ISO There has been a great deal of confusion concerning whether being in compliance with the medical device Good Manufacturing Practices (GMP) would successfully lead to obtaining ISO certification (with minimum changes and costs), or whether achieving ISO certification is going to be a long, expensive road. The ultimate success of your ISO
By Alan P. Schwartz Change for the sake of change is not always a good thing. But when change can be beneficial to all parties involved, getting mutual agreement on change may be easier and actual implementation faster. Such could be the case with proposed new good manufacturing practices (GMP) for the medical product manufacturing
mdi Consultants