This full-day workshop on May 22 at the MD& East conference will provide an overview of new FDA guidance and initiatives from a product design perspective, with practical examples of well written design control documents to support successful 510(k) premarket notifications. The workshop will provide a discussion of regulatory and quality issues to address when … continue reading
On occasion, medical device manufacturers have approached Aptiv Solutions and asked about the relationship between wireless devices and the Federal Communications Commission (FCC). Specifically, developers are curious about what role is played by the FCC in the regulatory approval of wireless medical devices in partnership with the FDA. While the FCC certainly does have jurisdiction … continue reading
For anyone familiar with the amount of research, effort, and investment that goes into the development of a medical device in the United States, the idea of a ‘do-it-yourself’ design philosophy that addresses patient care cheaply and quickly might seem far-fetched. A recent CNN.com article, however, examines the work of the Little Devices group at … continue reading
The May issue of Consumer Reports contained an article titled “Dangerous Devices” laying bare what it claimed was a culture of unsafe medical device approval practices entrenched at the FDA. In particular, Consumer Reports focused on the concept of substantial equivalence in the 510(k) regulatory process – coupled with anecdotal and statistical evidence regarding device … continue reading
The Food and Drug Administration will be holding a two-day expert advisory panel meeting this coming summer in order to evaluate the risks and benefits of ‘Metal-on-Metal’ (MoM) hip implant systems. The event, which will occur June 27-28, 2012, is being conducted by the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee … continue reading
The third edition of the IEC 60601-1 standard is on the horizon for global medical device companies manufacturing electrical equipment. IEC 60601-1 “Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and General Performance” began the revision process in 2005, but the full transition to the new version of the standard is slated … continue reading
Don’t forget to register for a free afternoon workshop for biopharmaceutical and medical device companies. We will address recent developments in the design and execution of adaptive clinical trials for streamlining drug development, and also discuss changing US and EU regulatory and statistical requirements for medical device clinical trials. This dual-track seminar is offered on … continue reading
Each year the Center for Devices & Radiological Health publishes its list of priorities for the upcoming 12-month period. Four key strategic areas will be the targets of the CDRH’s medical device policy for 2012, with a wide range of different initiatives designed to strengthen the Center’s ability to encourage medical device innovation while simultaneously … continue reading
Medical device companies often have difficulty bridging the financial gap between the research and development stage of their existence and profitability – that is to say, actually having a product ready for the market. Minnesota, a state which is home to a thriving medical technology industry, is in the process of considering a new law … continue reading
Join our regulatory and clinical trial experts at a free workshop for biopharmaceutical and medical device companies. We will address recent developments in the design and execution of adaptive clinical trials for streamlining drug development, and also discuss changing US and EU regulatory and statistical requirements for medical device clinical trials. This dual-track seminar is … continue reading
