QUALITY SYSTEMS AUDITING
Quality Audits That Power Compliance – Onsite or Anywhere!
At TESCON, we specialize in high-impact quality system audits, providing both onsite and remote solutions for medical device manufacturers and life science innovators.
Navigating the complexities of global regulatory environments requires more than just a checklist, it requires deep technical expertise and proactive strategy.
Our team of elite auditors is meticulously selected for their industry-leading precision and ability to translate complex international regulations into practical, business-aligned results.
The Inside Advantage for Quality Audits
Many of our senior consultants bring veteran experience from regulatory agencies and global industry leaders.
They apply this “inside-out” perspective to every engagement, whether you need a comprehensive gap assessment, a mock inspection to prepare for an FDA audit, or systematic supplier quality oversight.
From ISO 13485 and FDA QMSR to EU MDR compliance, we ensure your organization is prepared for any regulatory challenge.
Whether you are gearing up for your first major inspection, managing post-market surveillance audits, or seeking to optimize your internal quality controls, TESCON is your strategic partner.
We offer a suite of customizable audit programs designed to identify risks early, streamline your operations, and ensure you remain audit-ready at all times.
Partner with TESCON to transform your compliance program into a competitive advantage.
Our Audit Solutions
Gap Assessments
Identify and bridge regulatory shortcomings before they become compliance issues. We perform targeted gap assessments to ensure your processes align with FDA, EU MDR, and ISO standards, minimizing risks during high-stakes reviews.
Baseline QMS Audit
Establish a clear starting point for your quality journey. Our comprehensive baseline audits evaluate your existing QMS architecture, providing actionable insights to strengthen your foundations and prepare for long-term scalability.
Due Diligence Audits
Minimize risk in mergers, acquisitions, and partnerships. TESCON provides objective, rigorous due diligence audits to assess the regulatory health and compliance status of potential targets, protecting your investment and reputation.
FDA QMSR Audit (MedTech)
Ensure full adherence to the FDA’s Quality Management System Regulation (QMSR). We help you interpret and implement these requirements effectively, ensuring your device manufacturing operations meet the highest standards of safety and quality.
Mock FDA Inspection/ISO 13485 Audit
Face your next inspection with absolute confidence. Our mock audits simulate real-world regulatory scrutiny, testing your team’s readiness and identifying vulnerabilities in your ISO 13485 or FDA-focused quality systems.
Pre-Approval Inspection
Secure your market authorization with expert PAI preparation. We evaluate your readiness for pre-approval inspections, ensuring your documentation, manufacturing processes, and quality controls are flawless before the regulators arrive.
Outsourced Internal & Supplier Audits
Maintain continuous compliance without the internal burden. TESCON acts as your dedicated extension, executing thorough internal and supplier audits to ensure your supply chain remains robust and fully compliant with global standards.
Verification Audit
Validate the effectiveness of your remediation efforts. Our verification audits confirm that previous audit findings have been successfully resolved and that your corrective actions have been fully integrated into your daily workflows.
Certification Audit
Navigate the path to certification with expert guidance. We support you through every phase of the formal certification process, ensuring your documentation and systems demonstrate total compliance to certification bodies.
Remote Quality Management System Audits
Experience the efficiency of virtual compliance. We utilize advanced, secure remote auditing protocols to deliver the same high-level expertise as onsite visits, providing flexible, cost-effective oversight of your global quality systems.
Call Us Today for an Audit Readiness Check
15+
Years of Regulated Industry Experience
100%
Average patient Audit Readiness Focused