Life Sciences Posts

Five Years, Twenty-Six Days

Five Years, Twenty-Six Days

Mark Crawford

On October 15, the FDA published guidance regarding new efforts to reduce the average total wait time for 510(k) decisions from an average of 150 days in FY 2012 to 124 days in FY 2017. They will seek to do this by hiring more reviewers and investing more resources, both made possible by the Congressional approval of the Medical Device User Fee Amendments of 2012 (MDUFA III) earlier this year. (more…)

Integrating Risk Management into the Design Process

Mark Crawford

Ron Litke, a senior development engineer with Orchid Design, a division of Orchid Orthopedic Solutions, has over 15 years of design and project management for orthopedics and medical devices. In this brief interview he shares some thoughts about implementing risk management during the design and development process. (more…)

The FDA Devotes Almost Half of its Staff to Product Regulation – Shouldn’t They Eat Their Own Dog Food?

Compliance and Quality management is crucial issue for almost any business, large or small. No matter what medical product your company manufactures or services, it’s a virtual certainty that you are beholden to an array of different regulations, both internal and from the FDA such as cGMP quality systems. Ensuring that your company remains in compliance with these regulations and proving the quality and safety of products and services at all times is something that can’t be left to chance. (more…)