US FDA Consulting for Medical Device & IVD Manufacturers
Accelerate your entry into the United States market with our proven FDA expertise. We support medical device and IVD manufacturers in navigating complex regulatory pathways, ensuring market access.
Your FDA Success Story Starts Here
Your FDA Success Story Starts Here
Entering the US market requires deep understanding of evolving FDA requirements, submission strategies, and quality expectations. Companies often face delays due to unclear regulatory pathways, incomplete documentation, or misaligned quality systems.
At Qserve, we combine strategic expertise with hands-on implementation support to guide you from concept to market and beyond. We ensure efficiency, compliance, and long-term success.
Approved 510(K)'s
Countries for market access
Our FDA Consulting Services:
FDA Regulatory Strategy
We develop tailored regulatory strategies aligned with your product, intended use, and business objectives.
• FDA regulatory pathway selection (510(k), De Novo, PMA)
• Global market access strategies (US & international alignment)
• Regulatory roadmap development
• Early-stage regulatory support throughout development
FDA Submission Support
We guide you through all FDA submission pathways with a structured, efficient approach.
• 510(k) Premarket Notifications
• De Novo requests
• PMA submissions
• Pre-submissions (Q-sub program)
• Investigational Device Exemptions (IDE)
• Breakthrough Device & Safer Technologies Programs
• CLIA Waivers, EUA, HDE, PCCP
Quality Management Systems (QMSR)
We design, implement, or optimize your QMS to meet FDA requirements and can represent you during FDA inspections. The FDA has replaced the QSIT inspection methodology with a risk-based inspection framework aligned with ISO 13485 under the QMSR. We can help you prepare.
• 21 CFR Part 820 (QMSR) alignment
• MDSAP implementation
• Internal audits & supplier controls
• Inspection readiness & FDA mock audits
• Training and education programs
Technical, Clinical & Performance Support
Our multidisciplinary experts support throughout product development:
• Risk management & design controls
• Software development, cybersecurity & interoperability
• Electrical safety & electro magnetic compatiility (EMC)
• Biocompatibility, sterilization & shelf-life
• Preclinical studies
• Clinical studies, if required for D+FDA sudmission
• IVD analytical and performance studies and Point of Care considerations (POC)
Manufacturing & Process Validation
Manufacturing & Process ValidationWe support validation and quality engineering aligned with FDA expectations:
• Process validation & verification
• Manufacturing quality systems (GMP)
• Supplier qualification and controls
Post-Market Compliance & Lifecycle Support
Our services extend beyond market entry to ensure ongoing compliance.
• Post-market surveillance & vigilance
• Medical Device Reporting (MDR)
• Labeling & promotional review
• Design change impact assessments
• Establishment registration & device listing
• UDI / GUDID support
• US FDA Agent services
FDA Compliance & Remediation
We help you address regulatory challenges efficiently. Our team will collaborate with you to identify areas for improvement.
• FDA 483 observations & warning letters
• Requests for additional information (AINN)
• CAPA resolution
• Recall management
U.S. Agent
We act as your official U.S. Agent, serving as the FDA liaison and supporting communication, registration, and compliance for non-U.S. medical device manufacturers.
510(k) Submissions
We support in demonstrating substantial equivalence to a predicate device for US market clearance. We review your technical documentation and draft the submission documentation and upload in the electronic submission Template eSTAR.
FDA Pre-Submissions
Engage early with FDA to validate strategy, study design, and test plans. We optimize your pre-submission interactions.
Our Step-by-Step FDA Market Access Approach
We follow a structured methodology to reduce risk and accelerate timelines:
1. Initial Assessment
Evaluate product, classification, and regulatory risks
2. Regulatory Strategy Development
Define pathway, roadmap, and submission strategy
3. Design & Evidence Development
Support V&V, clinical and performance evidence
4. QMS Implementation & Inspection Readiness
Align your quality system with QMSR requirements
5. Submission Preparation & Review Support
Prepare and submit dossiers (e.g., eSTAR) and manage FDA interactions
6. Approval & Lifecycle Compliance
Support post-market compliance and long-term regulatory
Our Step-by-Step FDA Market Access Approach
We follow a structured methodology to reduce risk and accelerate timelines:
1. Initial Assessment
Evaluate product, classification, and regulatory risks
2. Regulatory Strategy Development
Define pathway, roadmap, and submission strategy
3. Design & Evidence Development
Support V&V, clinical and performance evidence
4. QMS Implementation & Inspection Readiness
Align your quality system with QMSR requirements
5. Submission Preparation & Review Support
Prepare and submit dossiers (e.g., eSTAR) and manage FDA interactions
6. Approval & Lifecycle Compliance
Support post-market compliance and long-term regulatory
Why Choose Qserve?
Why Choose Qserve?
- Deep FDA Expertise
Extensive experience with FDA submissions and FDA interaction, inspections, and compliance - Tailored Regulatory Solutions
Strategies aligned with product, company, and business objectives - Global Regulatory Perspective
Integrated support across US, EU, and international markets - Practical, Risk-Based Approach
Focus on efficiency, speed, and sustainable compliance
Couldn't find your question?
What FDA submission pathways does Qserve support?
Qserve supports the full range of FDA submission types, including 510(k) Premarket Notifications, De Novo requests, PMA submissions, Pre-submissions (Q-Sub), Investigational Device Exemptions (IDE), Breakthrough Device & Safer Technologies Programs, CLIA Waivers, EUAs, HDEs, and PCCPs.
How does Qserve help companies prepare for FDA inspections?
Qserve assists with aligning quality management systems to 21 CFR Part 820 (QMSR) and ISO 13485, conducting internal audits, implementing MDSAP, and running FDA mock audits to ensure your organization is fully inspection-ready under the FDA's current risk-based inspection framework.
Does Qserve only support companies entering the US market, or do they also help with ongoing compliance?
Qserve supports the full product lifecycle. Beyond market entry, they provide post-market surveillance, Medical Device Reporting (MDR), design change assessments, UDI/GUDID support, labeling review, and remediation services for issues such as FDA 483 observations, warning letters, and recalls.
Why do I need an U.S. Agent?
The Federal Drug Administration (FDA) requires a US Agent for foreign establishments that manufacture, prepare, or process devices imported into the United States. The US Agent must reside in the United States and be available to answer questions from the FDA during business hours. An Official Correspondent is designated as the individual responsible for maintaining the registration and device listing account during registration. Qserve acts as the US Agent and the Official Correspondent for establishments registered with the FDA.
What is included in the US Agent service?
- Assist FDA in communication with the foreign manufacturer
- Initial registration of the new establishment
- Annual update of registration and device listing records
- Assist FDA in scheduling inspections of the foreign establishment
- Initial listing of medical devices that will be imported
- Two hours of regulatory support/advice
- Qserve template to facilitate importation
What are the responsibilities of an U.S. Agent?
- Assist FDA in communications with the foreign establishment
- Respond to questions concerning the foreign establishment's devices that are imported or offered for import into the United States
- Assist the FDA in scheduling inspections of the foreign establishment
What are the responsibilities of the official correspondent?
- Manage registration and device listing accounts in the FURLS system (FDA Unified Registration and Listing System)
- Responsible for annual renewal of the FDA establishment registration
- Receives correspondence from the FDA for the registration and listing information for the foreign establishment
Relevant blogs
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Learn about the roles, responsibilities and legal requirements of a U.S. FDA Agent. Expect to read about compliance implications and common misconceptions.
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The new QMSR era: FDA inspections move from procedural QSIT audits to risk‑driven, lifecycle‑focused, ISO‑aligned regulatory examinations.
With February 2, 2026 fast approaching, read how to prepare for the FDA QMSR under ISO 13485 based on your current Quality Management System.