Our virtual and onsite FDA readiness audits provide a comprehensive compliance assessment, identifying gaps in documentation, processes, and staff readiness.

With expert evaluations and actionable recommendations, we help ensure your organization is fully prepared for FDA inspections.

Evaluation of the best regulatory pathway, including:

• Predicate identification
• Compliance with all applicable standards such as:
  • 21 CFR Part 820
  • ISO 13485
  • The European Union Medical Device Regulation (EU MDR) etc.
• Direct communication with regulatory agencies
• Guiding clients on submission and marketing requirements
• Supporting business objectives by:
  • Accelerating market entry
  • Reducing costs
  • Streamlining global compliance

Preparation of medical devices through:

• 510(k) Clearances
• Premarket Approval (PMA)
• De Novo Classification Request
• Humanitarian Device Exemption (HDE)
• Emergency Use Authorization (EUA)
• Breakthrough Devices Program
• Investigational Device Exemption (IDE)

And other regulatory submissions, including:

• Developing verification
• Validation
• Human Factors and Usability Engineering to Medical Devices

• Quality Systems (QS) & Medical Device Current Good Manufacturing Practices (CGMP)
• Risk Management
  • Quality Management System (QMS)/ Design History File (DHF) development
  • Risk analysis (FMEA, fault tree, root cause analysis)
• Process validation
• Statistical analysis to support regulatory requirements.

Engineering support for:

• Design controls
• Manufacturing processes changes
• Clinical trial strategy, ensuring compliance with regulatory expectations.

Pre/Post-Market Support:
We help navigate pre/post market regulatory requirements, including adverse event reporting and recalls.

Why Choose Our FDA Mock Audit Services?

✔ Ensure Compliance Readiness - Identify and address compliance gaps before the FDA inspection.

✔ Boost Staff Confidence - Train your team to handle FDA audits with ease.

✔ Strengthen Documentation - Improve record-keeping to meet FDA requirements.

✔ Enhance Process Efficiency - Optimize operations to align with regulatory expectations.

✔ Demonstrate Quality Commitment - Show regulators your dedication to safety and compliance.

What’s Included in Our Mock Audit?

🔹 Full Compliance Review - Comprehensive assessment of processes, SOPs, and documentation.

🔹 Facility & Process Inspection - Identify risks in manufacturing, quality control, and operations.

🔹 Staff Readiness Evaluation - Prepare your team for real-time FDA questioning.

🔹 Detailed Audit Report - Actionable insights with corrective recommendations.

🔹 Tailored Action Plan - Step-by-step guidance to fix compliance issues before the FDA arrives.

At Medically Engineered FDA Solutions LLC, we understand that early-stage companies and small businesses often face unique challenges—tight budgets, limited resources, and the need for agile support. That’s why we offer flexible partnership models tailored to your specific needs.

Whether you're seeking traditional consulting services, milestone-based engagements, or more integrated arrangements—including partial ownership, equity sharing, or hybrid compensation structures — we’re open to creative collaborations that align our success with yours.

Our goal is to grow with you, not just work for you. We believe in building long-term relationships that empower innovation and bring great ideas to market, faster and smarter.

Let’s explore a structure that works for your vision—and scale together.

When choosing a consultant, companies should consider the following:

Confidentiality Measures:

It’s essential that the consultant maintains strict confidentiality regarding proprietary information.

Area of Expertise:

Ensure the consultant specializes in the relevant product category (e.g., pharmaceuticals, medical or combination devices).

Experience with the FDA:

A consultant with a proven track record and familiarity with FDA processes can provide valuable insights.

Risk Management Approach:

Understanding how the consultant identifies and mitigates risks is crucial to Top FDA Compliance and Regulatory Consultants

Staying Updated:

The consultant should have a method for keeping abreast of regulatory changes.

FDA product consulting involves providing expert guidance to companies seeking to comply with the U.S. Food and Drug Administration’s (FDA) regulations. Consultants assist in navigating the regulatory landscape, ensuring that products such as drugs, medical devices, food items, and cosmetics meet all necessary safety and efficacy standards before reaching the market. ​

Navigating FDA regulations can be complex and challenging. Engaging with an FDA product consultant can help ensure compliance, expedite the approval process, and avoid potential pitfalls that could lead to costly delays or rejections. Consultants provide expertise in preparing necessary documentation, developing regulatory strategies, and communicating effectively with the FDA.

FDA product consultants typically specialize in areas such as:​

Quality System Implementation:

Ensuring that quality management systems meet FDA standards.

Regulatory Strategy Development:

Comprehensive plans to meet FDA requirements.​

Documentation Preparation:

Assisting in the creation and review of necessary submissions, such as 510(k) applications for medical devices. ​

Risk Management:

Identifying and mitigating potential compliance risks.​

Quality System Implementation:

Ensuring that quality management systems meet FDA standards.

Post-Market Surveillance:

Monitoring products after they enter the market to ensure ongoing compliance.

The 510(k) process is a premarket submission made to the FDA to demonstrate that a medical device is safe and effective, and substantially equivalent to a legally marketed device. The FDA typically reviews a traditional 510(k) within 90 days, though this timeline can extend if additional information is requested. Engaging with experienced consultants can help streamline this process and address any regulatory challenges.