Services

Regulatory Services for Medical Device Companies

From first-in-human studies to FDA clearance, Madan Regulatory provides the expertise and infrastructure to move your device program forward with precision.

FDA Submission Strategy & Consulting

510(k) · PMA · De Novo · IDE · EUA

Navigating the FDA's device review pathways requires more than documentation — it requires a strategy built on deep knowledge of agency expectations, predicate device selection, and risk classification. Madan Regulatory develops and executes submission strategies tailored to your device's technology, intended use, and target market.

Outcome

Clients receive a clear regulatory roadmap, submission-ready documentation, and direct support through FDA review cycles.

Capabilities

510(k) premarket notification preparation and submission management
PMA application strategy, modular submissions, and panel preparation
De Novo classification requests for novel, low-to-moderate risk devices
Investigational Device Exemption (IDE) applications for clinical studies
Emergency Use Authorization (EUA) strategy and submission support
FDA meeting preparation (Pre-Sub, Q-Sub) and response strategy

Clinical Trial Design & Oversight

GCP Compliant · FDA-Aligned Protocols · IDE Studies

Clinical evidence is the foundation of most device submissions. Madan Regulatory designs studies that generate the data FDA reviewers expect — with the statistical rigor, endpoint selection, and protocol structure to withstand scrutiny. Our team provides ongoing oversight throughout the study lifecycle.

Outcome

Studies designed to produce defensible clinical evidence that supports regulatory submissions and withstands FDA review.

Capabilities

Clinical protocol development and statistical analysis plan design
Endpoint selection and sample size justification aligned with FDA guidance
Investigational site identification, qualification, and initiation
Clinical monitoring and Good Clinical Practice (GCP) compliance oversight
Data management, adverse event reporting, and safety monitoring
Clinical study reports and integrated summary of safety and effectiveness

IRB Services

In-House IRB · Expedited Review · Full Board Review

Madan Regulatory operates its own Institutional Review Board, providing independent ethical review of clinical investigations involving human subjects. Unlike firms that rely on external IRBs, our in-house board works in direct coordination with our regulatory and clinical teams — eliminating the scheduling delays and communication gaps that slow most programs.

Outcome

Integrated IRB oversight that moves in lockstep with your regulatory strategy — not on a third party's schedule.

Capabilities

Initial protocol review for clinical investigations and feasibility studies
Expedited review for minimal-risk research and protocol amendments
Full board review for greater-than-minimal-risk investigations
Informed consent document review and approval
Continuing review and annual renewal management
Unanticipated problem and serious adverse event reporting review

Regulatory Compliance & Audits

21 CFR Part 820 · ISO 13485 · 21 CFR Part 11

Regulatory compliance is not a one-time event — it is an ongoing operational discipline. Madan Regulatory conducts structured audits and gap assessments against FDA Quality System Regulation and ISO 13485, identifying vulnerabilities before they become observations or warning letters.

Outcome

A compliance posture that withstands FDA inspection and positions your organization for sustainable regulatory success.

Capabilities

Quality Management System (QMS) gap assessments against 21 CFR Part 820
ISO 13485 readiness audits and certification preparation support
Pre-inspection readiness assessments and mock FDA audit preparation
CAPA (Corrective and Preventive Action) system review and remediation
21 CFR Part 11 electronic records and electronic signatures compliance
Warning letter and 483 observation response strategy and remediation

Ready to Discuss Your Program?

Reach out directly to discuss your device's regulatory pathway and how Madan Regulatory can support your submission strategy.

[email protected]