FDA Regulatory Consulting Solutions
Bringing a medical device to the U.S. market means navigating one of the most rigorous regulatory systems in the world. With Sobel’s expertise in FDA regulatory consulting, your company gains tailored support for a confident path to FDA submission.
This solution is designed for companies entering or operating in the U.S. medical device market:
Medical Device Manufacturers
needing expert guidance to prepare 510(k) or PMA submissions with confidence.
International Companies
looking for FDA regulatory consulting and U.S. Agent services to secure market access.
Startups and Innovators
seeking strategic regulatory planning to accelerate approval and reduce time-to-market.
Regulatory Affairs Teams
requiring technical support with QMS, ISO 14971 risk management, and submission files.
Facilitating Your FDA Compliance Journey
The U.S. medical device market is highly regulated, with strict requirements under FDA pathways such as 510(k) and PMA. From documentation and safety evaluations to QMS compliance, companies often face recurring doubts when preparing for FDA submissions.
For many businesses, navigating FDA regulatory consulting raises essential questions:
What is the FDA 510(k) process for medical devices?
The 510(k) process is the most common FDA pathway for medical devices. Companies must demonstrate that their device is substantially equivalent to a legally marketed predicate device. This involves preparing and submitting detailed technical documentation. With FDA regulatory consulting support, manufacturers can identify the right predicate and streamline their submission.
When is a PMA (Premarket Approval) required?
PMA is the most stringent FDA pathway, required for Class III medical devices that support or sustain human life or present high risk. It demands robust clinical data, safety evaluations, and comprehensive documentation. Sobel assists with PMA strategies, guiding companies through planning, testing, and submission.
What are FDA requirements for Quality Management Systems (QMS)?
The FDA requires manufacturers to comply with 21 CFR Part 820, the Quality System Regulation (QSR). This includes processes for design control, production, complaint handling, and corrective actions. Sobel provides QMS consulting and training, aligning your system with FDA expectations and international standards.
What is the role of a U.S. Agent for foreign manufacturers?
For companies without a U.S. presence, appointing a U.S. Agent is mandatory. The agent serves as the point of contact between the manufacturer and the FDA, handling communications, inspections, and regulatory requests. Sobel also offers U.S. Agent services, for a smooth interaction with regulators.
With Sobel as your partner, your company gains clarity, expert guidance, and full support across all regulatory fronts.
FDA Regulatory Consulting with Sobel
The path to FDA approval for medical devices involves complex regulations and detailed technical requirements. From 510(k) and PMA submissions to QMS compliance and risk management, every detail must be carefully managed to secure approval.
Sobel provides specialized support to make this journey more efficient. Our consultants assist with regulatory strategy, preparation of robust submission files, biological and clinical evaluations, and alignment with FDA expectations.
For international companies, Sobel acts as your U.S. Agent, bridging communication with the FDA and supporting inspections, notifications, and ongoing obligations.
With Sobel’s expertise, you reduce regulatory risks, accelerate approval, and gain confidence to bring innovative medical devices into the U.S. market.
Our services in regulatory compliance for medical devices
Sobel supports manufacturers with comprehensive FDA regulatory consulting, covering each step needed for U.S. market entry and ongoing compliance.
- Clinical Evaluation (CEP, CER)
Support for CEP and CER development, including strategic planning, literature reviews and more.
- US Agent Service
Navigate market access in the U.S.A. with Sobel as your device US Agent.
- Regulatory Consulting Services
Support for Premarket Notification 510(k), FDA submissions, registration, UDI, and more.
- Supplier Audit and Qualification
Strengthen your supply chain with supplier audit and qualification services.
- Regulatory Affairs Training
Expert-led training programs that strengthen risk management and compliance.
Unlocking opportunities in Brazil’s medical device market
Brazil’s medical device market is competitive, and navigating Anvisa’s requirements can be time-consuming. Sobel helps transform this challenge into an opportunity, giving your company the clarity and resources needed to reach the market faster and stronger.
By choosing Sobel, you gain:
Complete guidance for Anvisa compliance in Brazil, from strategy to approval.
Lower risk of delays, non-conformities, or regulatory setbacks.
Expertise in dossiers, GMP, INMETRO, and post-market obligations.
Local support through Registration Holder services and regulatory representation.
Ready to bring your medical device to the U.S. market?
Sobel manages the regulatory process — from strategy to submission — so your team can focus on innovation.
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