The best time to consider compliance is before the work begins. Companies can save thousands of hours of effort and reach their markets months faster if their development process follows recognized standards which are straightforward to implement.
Quantum Now LLC helps ultrasound device companies with regulatory affairs and standards to comply with the United States Food and Drug Administration (FDA) and the International Electrotechnical Commission (IEC). FDA filings include Pre-market Notifications (510(k)), Investigational Device Exemptions (IDE), and Pre-market Approvals (PMA).
Specialties include:
Assistance is available directly, or through subcontracts to intellectual property law firms and compliance consultants.