Clients are being notified of a recent development from the Notified Body BSI that it will be increasing the number of unannounced ISO audits for high-risk devices or for noncompliant manufacturers. The following Industry Update provides insight about their thinking on this new initiative. Background: After a trial period in March 2014 and a round
mdi’s Regulatory Consultant Mr. Aditya Sukthankar on the panel of American Ceramic Society in Ohio, July 2014 Aditya Sukthankar on the Panel of American Ceramic Society Aditya Sukthankar, Regulatory Consultant, mdi Consultants Inc. was invited by the American Ceramic Society to be a panel speaker for the Biomaterials Meeting in Ohio on 31st of July
mdi Consultants Inc. is the leading provider of quality assurance, regulatory compliance and clinical services to the Medical Device, Pharmaceutical and Food industries. mdi Consultants, Inc., is a Medical Device Consulting, U.S. Agent, CE mark, ISO, Pharmaceutical and Quality Assurance, Regulatory Consulting company and Authorized Agent. The “Operon Strategist” is consultancy firm working towards the
Our analysis of recent FDA warning letters issued to the dietary supplements industry signaled the FDA turned its GMP enforcement emphasis to the importers, distributors and private labelers of dietary supplements. However, time and time again, we see that many of our clients mistakenly believe that manufacturers or contract manufacturers of dietary supplements are the
Background: Around 25% of the drugs being imported into the US are manufactured in India and in the past few years Indian drug makers were not being audit under tight compliance by the FDA. But due to some recent mishaps and bad experiences with some Indian companies like Ranbaxy and Wockhardt, the FDA has decided
This is to announce that Alan P. Schwartz, Executive VP, mdi Consultants, Inc. has been invited to join the Editorial Advisory Board of MDT (Medical Device Technology). Alan has also been on the Editoral Advisory Board of GXP for over 10 years.
Present Scenario: The US Food and Drug administration is appealing for feedback on its proposal to bring into line its medical device labeling requirements with those in the EU by permitting the use of standardized stand alone symbols on device labels providing these are clarified in a supplementary symbols glossary. Regulations in the US at
Background: The Department of Health and Human Services (HHS), of which the Food and Drug Administration (FDA) is a part, recently published “Contingency Staffing Plan for Operations in the Absence of Enacted Annual Appropriations.” Essentially, this Plan is the SOP for how HHS and FDA will operate under the current partial government shutdown. Under this
Physician Payment Sunshine Act Clients will be interested to know that American Medical Association (AMA) being the only governing body for physicians has come up with this new act called as Physician Payment Sunshine Act. This act demands the manufacturers of drugs, medical devices and biologics to record certain items and payments they have made
In the future, you will be able to submit applications to Health Canada through the US Food and Drug Administration’s gateway. Health Canada is collaborating with its U.S. regulatory counterparts to reduce regulatory burden for health products, and to move closer to an automated environment for the exchange, review and management of information supporting the
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