Many of our clients want to understand what it will take to get a successful launch of your device. Here is some insight to what you should be looking for to assure you give your technology a chance of getting your market to notice. Medical marketing can be a daunting task. For the start-up to
The FDA has issued a total of 24 warning letters to the medical device industry for the fiscal year 2018. That is two WLs per month. WOW, that is AMAZING. With hundreds of inspections being conducted by the FDA, worldwide, such low number of warning letters would make one believe that the MEDICAL DEVICE industry
FDA compliance has been much more difficult to deal with By Alan Schwartz What is going on with the FDA? Is the FDA on a war-path judging by the ever increasing number of facility inspections? Or is it like any bureaucracy, they have taken on too much work without clearly assessing the consequences for companies,
Recently, there was a warning letter issued to a company (dated Sept 11, 2012) that was registered as a “specification developer” with the FDA. The inspection of the company was conducted by the FDA on June 7, 2012. However, this article is not about the company and what they manufactured or what they distributed. This
GFda Information Artical FDA Says A BIG NO. Find out WHY Background and some few Clarifications of some definitions by FDA: Dietary Supplement: A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet which includes: vitamins, minerals, herbs or other botanicals, amino acids, and substances such
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
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