Built on Regulatory Expertise. Defined by Precision.
Madan Regulatory was founded to give medical device companies access to the kind of deep, integrated FDA expertise that has historically been available only to large organizations with in-house regulatory affairs teams.
Accelerating Safe, Effective Medical Devices to Market
The path from device concept to FDA clearance is long, technically demanding, and unforgiving of strategic missteps. Madan Regulatory exists to shorten that path — not by cutting corners, but by applying the right expertise at the right stage of your program.
We work exclusively with medical device companies, which means our regulatory knowledge is deep and current. We understand how FDA reviewers think, what submission deficiencies look like before they happen, and how to structure a clinical program that generates the evidence the agency expects.
Scientific Rigor
Every recommendation we make is grounded in FDA guidance, published literature, and direct experience with the agency's review process.
Integrated Oversight
Our in-house IRB, clinical team, and regulatory consultants work as a single unit — not as separate vendors passing documents between them.
Client Accountability
We are measured by your program's outcomes. Clearance, approval, and successful clinical execution are the metrics that matter.
Deep Experience Across the FDA Device Pathway
510(k) & De Novo Submissions
Predicate device strategy, substantial equivalence arguments, and performance testing protocol design for Class II devices.
PMA Applications
Pre-market approval strategy for Class III devices, including modular submissions, panel preparation, and post-approval study design.
IDE & Clinical Investigations
Investigational Device Exemption applications and clinical study design for devices requiring clinical evidence of safety and effectiveness.
Institutional Review Board
In-house IRB providing independent ethical review of clinical investigations — initial review, continuing review, and protocol amendments.
Quality Systems (21 CFR Part 820)
Quality Management System development, gap assessments, and audit preparation aligned with FDA QSR and ISO 13485.
FDA Interactions & Meetings
Pre-Submission (Q-Sub) meeting preparation, FDA correspondence strategy, and response management throughout the review cycle.
Our IRB: Independent Review, Integrated Strategy
Madan Regulatory operates its own Institutional Review Board — a formal, independent body responsible for the ethical review and oversight of clinical investigations involving human subjects.
Having an in-house IRB is a structural advantage that most regulatory consulting firms cannot offer. It means your protocol review, regulatory strategy, and clinical oversight are coordinated by a single team — eliminating the scheduling delays, communication gaps, and accountability diffusion that come with third-party IRB arrangements.
IRB at a Glance
Work With Us
If you are navigating an FDA pathway for a medical device, we would welcome the opportunity to discuss your program.