Medical Device Regulatory Submissions
Whether it's a short question about a submission issue, a review or a request to draft the entire submission, Nilo Medical Consulting has extensive experience with Original PMAs, all types of PMA Supplements (including 30 Day Notices), clinical trial IDEs, 510(k)s, 513(g) requests, and de novo submissions.
Combination Product Regulatory Submissions
The Nilo Medical Consulting Group is well-equipped to handle the complex regulatory requirements of combination products where the regulations span across different centers at the FDA. Nilo Medical Consulting has direct experience working with combination products such as drug-eluting stents and growth-hormone infused bone graft material.
Verification & Validation Testing Requirements
Nilo Medical Consulting is available to provide performance testing consulting so that the right testing is conducted the first time to meet regulatory requirements, saving time and money.
Approaching the FDA can be an intimidating prospect for many companies. Meetings are limited in time and need to sufficiently explain complex issues. Nilo Medical Consulting has experience on both sides of the table and is available to advise companies on the best way to get the most useful information from any FDA interaction.
Quality Systems & Post-Market Regulations
Nilo Medical Consulting is well-versed in the quality system regulations such as 21 CFR 820, ICH guidelines, and ISO 13485.
Has your company just started its own regulatory department or hired new employees? Nilo Medical Consulting is available to teach seminars to overview or go in-depth in the FDA regulations on both the pre-market and post-market sides.