Medical Device Regulatory Submissions
Our expertise encompasses 510(k)s, De Novos, PMAs, PMA Supplements, HDEs, IDEs, Q-submissions, Breakthrough Device & STeP Designations, and 513(g)s, while also managing EU MDR Technical Dossiers, follow-ups with regulatory bodies to resolve deficiencies and answer questions, and Registration & Listing.
Combination Product Regulatory Submissions
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. We have direct experience working with combination products such as drug-eluting stents and growth-hormone infused bone graft material.
Verification & Validation Testing Requirements
Our team provides performance testing consulting so that the right testing is conducted the first time to meet regulatory requirements, saving our clients time and money.
FDA Meetings
We know that approaching the FDA can be an intimidating prospect. Meetings are limited in time and need to sufficiently explain complex issues. We have experience on both sides of the table and can facilitate meetings as well as advise companies on the best way to get the most useful information from any FDA interaction.
Quality Systems & Post-Market Regulations
We provide comprehensive guidance and development of a QMS that meets 21 CFR 820 and ISO 13485 requirements, alongside risk management in compliance with ISO 14971 to lead development and V&V activities. Our expertise includes conducting regulatory change impact assessments, managing UDI requirements, resolving 483 observations, and preparing for both internal and regulatory audits.
Education
All-encompassing staff training in regulatory, quality, risk, and clinical requirements, conducted either remotely or onsite, tailored specifically to your unique products and operational needs. Additionally, specialized Good Clinical Practice (GCP) training ensures adherence to global standards in clinical research conduct.