US Medical Devices Regulatory Services

Navigating the complex regulatory landscape of the U.S. medical device industry requires deep expertise, meticulous documentation, and a well-defined strategy. At iMDR MedTech, we specialize in comprehensive regulatory consulting for medical devices, ensuring smooth FDA approvals, compliance with 21 CFR Part 820 (QSR), ISO 13485, and successful market entry.

With a team of 200+ global regulatory experts, we help medical device manufacturers, importers, and distributors streamline regulatory submissions, optimize compliance processes, and avoid costly delays.

Understanding the US FDA Regulatory Framework for Medical Devices

The U.S. Food and Drug Administration (FDA) regulates medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Compliance with FDA regulations is mandatory for manufacturers looking to sell medical devices in the U.S. market.

Key FDA Regulatory Requirements for Medical Devices

Our team at iMDR MedTech provides end-to-end regulatory support, helping you navigate each step efficiently.

Our Comprehensive US Medical Devices Regulatory Services

✅ Medical Device Classification & Regulatory Strategy Development

Determining the correct FDA classification is crucial to selecting the right regulatory pathway. Our experts:

✅ 510(k) Premarket Notification – FDA Clearance Support

A 510(k) submission is required for Class II medical devices unless exempt. Our team:

✅ Premarket Approval (PMA) – High-Risk Devices

Class III devices require a rigorous Premarket Approval (PMA) application. We support:

✅ De Novo Classification – For Innovative Medical Devices

For devices with no predicate (novel technology), our De Novo submission support includes:

✅ FDA Investigational Device Exemption (IDE) & Clinical Trial Support

For devices requiring clinical testing, we assist with:

✅ Quality System Regulation (QSR) – 21 CFR Part 820 Compliance

All U.S. medical device manufacturers must comply with FDA’s QSR requirements, covering:

✅ FDA Establishment Registration & Device Listing

We assist medical device manufacturers, importers, and foreign companies in:

✅ Labeling, Unique Device Identification (UDI) & Marketing Compliance

✅ FDA Inspections, Compliance Audits & 483/Warning Letter Responses

✅ Post-Market Surveillance, MDR & Recall Management

Why Choose iMDR MedTech for FDA Regulatory Services?

200+ Global Experts – A team of experienced regulatory consultants, auditors, and engineers.
Regulatory Excellence – Deep expertise in FDA QSR, ISO 13485, and international compliance.
Accelerated Market AccessOptimized 510(k), PMA, and De Novo pathways to reduce time to market.
Tailored Solutions – Custom strategies for startups, SMEs, and multinational manufacturers.
Global Reach – We support companies worldwide in achieving FDA and international regulatory compliance.

Get Your Medical Device FDA-Ready with iMDR MedTech

With iMDR MedTech, you gain a trusted regulatory partner dedicated to simplifying FDA compliance and fast-tracking approvals. Whether you need support with 510(k) submissions, PMA applications, QMS implementation, or FDA audits, we’re here to help!

📩 Contact us today at info@imdrmedtech.com for expert guidance on US Medical Devices Regulatory Services!