Quality Systems Auditing

Quality Audits That Power Compliance – Onsite or Anywhere.

At QualityHub, we bring deep expertise in delivering both onsite and remote quality system audits for manufacturers of medical devices, pharmaceuticals, combination products, and biologics.

Operating in a globally regulated industry? We have you covered. Our elite team of auditors is handpicked for their technical precision, regulatory know-how, and product-specific insight to ensure every audit is effective and efficient.

Many of our auditors are former FDA investigators that apply real-world experience and a sharp ability to apply regulatory requirements to even the most complex of products. From compliance audits to gap assessments and technical reviews, we cover all US- and EU-regulated areas while aligning with global regulatory expectations.

Preparing for your first FDA inspection? Navigating post-inspection certification audits? Need support with supplier or global internal audits? Then let QualityHub be your company’s one-stop solution.

Explore our 10 customizable audit programs below and discover how we tailor every engagement to meet your company’s compliance goals.

When you need a deeper, more collaborative look at your quality system, a formal audit isn’t always the proper tool. That’s where QualityHub’s gap assessments come in. Designed to be interactive and solutions-focused, these assessments foster open communication while identifying detailed quality concerns across specific areas or processes.

Whether conducted after an audit, inspection, or in response to known deficiencies, our gap assessments provide actionable insights that inform quality improvement and corrective action plans. They can also focus on technical elements, such as product-specific risk management files, design history files, or master batch records, offering your company a clear path to improvement.

Unlike traditional audits, gap assessments offer added value through coaching, shared best practices, and tailored recommendations from experienced quality experts.

Whether you need a full-scale global assessment or a focused site review, we deliver comprehensive audits tailored to your needs. Our audits evaluate compliance with FDA regulations and conformity with international ISO standards, ensuring your operations meet regulatory expectations and industry best practices.

We don’t just stop at manufacturing sites. Our expert auditors also evaluate:

  • Design Centers
  • Corporate Operations
  • Complaint Intake Centers
  • Distribution Centers

While many clients turn to us after receiving an FDA-483 or Warning Letter, proactive audits are a powerful way to stay ahead of potential risks. We’re also a trusted partner during mergers and acquisitions, conducting baseline audits that bring clarity and confidence to complex transitions.

When it comes to mergers and acquisitions, hidden compliance issues can turn a promising deal into a costly mistake. QualityHub’s independent due diligence audits give you the clarity you need to make informed, risk-based decisions – before the paperwork is signed.

We conduct in-depth quality system audits across selected facilities or product lines, evaluating compliance with FDA regulations and conformity with international ISO standards. Our findings help your company assess potential liabilities, anticipate post-acquisition investments, and budget confidently for quality and compliance improvements.

QualityHub delivers quality system audits that mirror the FDA’s own approach, which was adapted to reflect the agency’s adoption of its Quality Management System Regulation (QMSR) in 2026.

These audits are designed to evaluate your medical device facility with the same level of rigor the FDA would apply, giving you a clear view of where your MedTech company stands.

Our QMSR audits focus on major quality management subsystems, including Management Controls, Design Controls/Design and Development, Production and Process Controls, and Corrective and Preventive Action (CAPA) – along with other related requirements critical to compliance.

Often conducted as mock FDA inspections, these audits not only assess your systems but also provide valuable practice for your team in confidently presenting documents, records, and procedures to demonstrate regulatory compliance.

Clever companies don’t wait for the FDA to show up for a facility inspection; rather, they prepare. We have assisted countless organizations uncover and close compliance gaps before agency investigators arrive, setting the stage for a smoother, more successful inspection. Many of our clients request a mock FDA inspection as a proactive step to ensure their teams and systems are ready. These audits closely mirror actual inspections, but with added value including interactive “hats-off” sessions that provide real-time coaching and practical training to instruct your staff on how to engage confidently and professionally with regulators.

QualityHub will send to your company a former FDA investigator to conduct a no-holds-barred, real-time mock inspection. Over the course of three or four workdays, our expert arrives unannounced to team members, steps into character, and performs a full-scale inspection – just like the FDA would. From the moment our expert walks through your company’s front door, they’ll scrutinize your policies, procedures, records, and operations. They’ll observe your team in action, conduct interviews, sample documentation, and test your preparedness against FDA expectations and industry best practices.

QualityHub also performs mock ISO 13485 audits as part of our services, offering the same depth of insight and preparedness for companies operating under global medical device quality standards. These audits help ensure your quality system aligns with international expectations and can withstand the scrutiny of notified bodies and regulatory authorities.

We perform FDA pre-approval audits to help companies prepare for and successfully navigate facility inspections. These audits are heavily focused on the areas FDA typically inspects during a pre-approval inspection, including:

  • Design Controls/Design and Development
  • Risk Management
  • Production and Process Controls

Trusted by industry leaders, our pre-approval audits empower companies to confidently prepare for commercial launch, minimizing risks and maximizing approval success. Join our clients who have achieved outstanding results by partnering with QualityHub.

In the highly regulated world of medical devices, drugs, and biologics, internal audits and supplier audits aren’t optional – they’re essential. QualityHub provides expert support for both, ensuring full alignment with FDA and global regulatory requirements across your quality management system.

Whether you need a comprehensive audit or a focused technical assessment of a specific site or supplier because of product concerns, complaints, or other quality issues, QualityHub has you covered. Our team helps reduce the risks tied to outsourced manufacturing and supplied materials, safeguarding both product integrity and regulatory compliance.

We also understand the delicate balance of auditing suppliers without straining valuable relationships. That’s why leading regulated manufacturers trust QualityHub to represent them with professionalism, precision, and discretion.

Many organizations turn to verification audits to validate the effectiveness of corrective actions taken in response to prior audits, or FDA-483 inspectional observations and agency warning letters. Our targeted audits provide a comprehensive review to confirm that your corrective and preventive measures are not only implemented but fully embedded with robust, documented evidence.

Our verification audits meticulously sample and assess key documents and records tied to your recently executed corrective actions to ensure they meet regulatory standards and drive measurable improvements. Partner with us to demonstrate your commitment to compliance, minimize risk, and build lasting trust with regulatory bodies.

When the FDA requires an independent third-party expert to conduct a comprehensive quality system audit – and submit certification reports – timing is critical. These audits typically occur before, during, and after remediation efforts and are often triggered by:

  • Recidivist Warning Letters
  • Corporate Warning Letters
  • Consent Decrees

At QualityHub, our deep expertise in the certification process gives your companies the tools to effectively address enforcement actions and maintain a strong, compliant quality system under intense regulatory scrutiny.

In today’s ever-evolving business landscape, traditional onsite audit programs – whether internal or supplier – can be disrupted, making it difficult to stick to audit schedules or respond quickly to urgent compliance needs. This can leave your organization vulnerable to regulatory noncompliance.

The solution? Go remote.

Remote audits offer a flexible, efficient way to keep your quality system in check without the added costs of travel. Whether you’re managing internal audits or assessing suppliers, remote auditing helps you stay compliant, control costs, and keep operations moving safely and effectively.

QualityHub specializes in delivering high-impact remote audits backed by:

  • A proven audit methodology
  • Strategic planning and real-time communication
  • Cutting-edge technology
  • A team of expert, industry-seasoned auditors

With QualityHub, you get more than just a remote audit – you get peace of mind that your compliance and quality system are in expert hands.

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