Regulatory Support
Expanding into the U.S. medical device market is an opportunity with high potential—but navigating the FDA’s regulatory pathways can be a challenge. Between submission requirements, quality system regulations, and post-market expectations, even experienced teams can feel overwhelmed.
But you can get strategic regulatory guidance for U.S. market access!
With Sobel, you can count on expert Regulatory Services for medical devices tailored to U.S. FDA requirements. Whether you’re preparing a 510(k) or PMA submission—or updating an existing product—we help you simplify compliance and accelerate your path to approval.
How We Support Your FDA Regulatory Process
Regulatory Services support manufacturers in meeting the U.S. Food and Drug Administration’s regulatory requirements for medical device approval and compliance. This can include classification, documentation, submission, and post-market strategy.
Here’s what Sobel delivers as part of its Regulatory Services FDA offering:
Assist with device classification, product code, and applicable FDA regulation number
Identify and validate the proper predicate device for 510(k) submissions
Prepare complete 510(k), PMA, or other submission files, including guidance on structure and content
Review and support labeling requirements for the U.S. market
Perform detailed regulatory gap assessments with actionable guidance
Respond to FDA review comments and assist with resubmissions
Provide ongoing regulatory support for post-market obligations, device modifications, and FDA updates
Why do you need this service?
With expert support, you avoid common errors that delay approval. We help you move from submission to clearance with greater efficiency.
For international manufacturers, we provide step-by-step guidance tailored to FDA expectations—bridging knowledge gaps and regulatory differences.
Regulatory compliance doesn’t stop at approval. We help you manage changes, updates, and quality system adjustments as your product evolves.
Remember: FDA compliance is a non-negotiable part of entering and staying in the U.S. market.
With the right strategy and technical guidance, you reduce regulatory risk and bring your device to the U.S. market with confidence.
Looking for FDA Regulatory Assistance?
At Sobel, we combine regulatory expertise with hands-on support to help you meet FDA requirements without unnecessary delays. From submission to post-market, we’re with you every step of the way.
Don’t let regulatory hurdles slow you down. Partner with Sobel Consultancy for expert FDA guidance and a smooth path to U.S. market approval.
