Medical device R&D spending expected to rise through 2018
July 27, 2017
By Neozene

An Emergo survey of medical device companies finds that a higher percentage of smaller firms plan to increase their research and design spending over the next year than mid- and large-sized firms. The survey of 543 medical device executives in North America, Europe and Asia revealed not only planned R&D spending differences between smaller respondents (those with 50 or fewer employees) and larger firms (those with 50 or more employees), but also different business priorities driving those R&D spending plans. Medical device R&D spending overall set to increase in 2018

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New FDA Guidance Explains Electronic Record Requirements for Medical Device Clinical Trials
July 25, 2017
By admin

US Food and Drug Administration medical device regulators have published new draft guidance recommending proper use of electronic records and signatures in clinical investigations. The new guidance applies to clinical trial sponsors and investigators as well as Institutional Review Boards (IRB) and clinical research organizations (CRO) that must comply with 21 CFR Part 11 regulations pertaining to electronic records and signatures. The FDA requires that electronic records and signatures are reliable and trustworthy, and that validations of electronic systems are carried out using risk-based approaches. Types of electronic records covered by the

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Consent Decrees
July 6, 2017
By Devin McElroy

The FDA, this morning, issued a press release for a consent decree issued against Medistat by a U.S. District Judge (see attached article for details). What is a consent decree and what actions cause one to be issued? A consent decree is requested by the FDA and issued by a Federal Judge against a company that has had numerous, unresolved violations against U.S. regulations for medical device or pharmaceutical manufacturing. Typically this process starts years before with a series of FDA Form 483 (Notice of Inspection) findings issued against a

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