Medical Device Regulatory Services

FDA 510(k) Premarket Notification — Traditional, Special & Abbreviated

We prepare complete 510(k) submissions, identify predicate devices, and manage FDA interactions through clearance.

FDA De Novo Classification Requests

For novel low-to-moderate risk devices without a predicate, we guide you through De Novo classification to establish a new device type.

FDA Establishment Registration & Device Listing

We handle annual establishment registration and device listing in FDA's systems to keep you in full compliance.

UDI System Implementation & GUDID Database Submission

We assign UDI labels and submit device identifiers to FDA's GUDID database to meet traceability requirements.

Quality Management System (QMS) — ISO 13485 & QMSR Compliance

We build and audit QMS documentation to meet ISO 13485 and FDA's QMSR, supporting your path to certification.

FDA Form 483 Response & Warning Letter Remediation

We draft 483 responses and corrective action plans to address FDA observations and close out warning letters.

Health Canada Medical Device Licence (MDL) Applications — Class II, III, IV

We prepare MDL applications ensuring alignment with Health Canada's technical and clinical requirements.

Health Canada MDEL (Medical Device Establishment Licence)

We manage your MDEL application so your facility is licensed to import, distribute, or manufacture devices in Canada.

Dual-Jurisdiction Strategy — FDA + Health Canada Simultaneous Submissions

We align documentation and timelines to pursue FDA and Health Canada clearance in parallel, saving time and cost.

Post-Market Surveillance & Adverse Event Reporting (MDR/CMDR)

We set up PMS systems and handle MDR/CMDR reporting to keep you compliant after market entry.

Clinical Trial & IDE (Investigational Device Exemption) Support

We assist with IDE applications and support the clinical study process required for investigational devices.