BLOG
Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
FDA Guidance Advises Device Makers to Think About Home-Use
Medical device manufacturers would be well-advised to address any potential risks associated with home-use products at t [...]
FDA Spreads Regulatory Love Nationwide
Detroit may be struggling with bankruptcy. However, in a flurry of activity that would make industrialist Henry Ford pro [...]
Time to Take a Closer Look at FDA MDDS Moves
The FDA recently released a new draft guidance document for Medical Device Data Systems (MDDS). The FDA defines MDDS as [...]
FDA Lets MDDS Off The Regulatory Hook
FDA won't enforce compliance with regulatory controls that apply to medical image storage devices (MDDS) and medical ima [...]
Unprecedented Energy Demand on Aging Grid: Important Discussions at NYISO Energy Conference
New York Independent System Operator (NYISO) had their 2014 Energy Conference in New York City at the end of June. The t [...]
FDA Guidance on How to Address Inaccurate Online Claims Against Medical Device or Drug Manufacturers
Distilling the FDA Guidance on How to Address Inaccurate Online Claims Against Medical Device or Drug Manufacturers: If [...]

