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Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
FDA IDE Guidance Offers Industry Important Clarity
In its August 19 guidance for Investigation Device Exemption (IDE) Clinical Investigators, the FDA attempts to better o [...]
Cybersecurity & Reliability Assurance Initiatives Top Priority at NERC Board Meetings
NERC held its Board of Trustees (BOT) and Member Representatives Committee (MRC) meetings in Vancouver, BC on August 13 [...]
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The FDA recently released a new draft guidance document for Medical Device Data Systems (MDDS).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 [...]
