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FDA Compliance and Quality

Tech-Medical Services, Inc. operates a structured Quality Management System designed to support consistent product quality, traceability, and continuous improvement. Quality and compliance are treated as operating disciplines — not paperwork.
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FDA Registered Facility

FDA Registered Establishment

At Tech-Medical, INC we bridge the gap between advanced technology and clinical excellence.
We are committed to maintaining the highest standards of safety and transparency in
accordance with FDA guidelines and best practices.

  • Regulatory Status: Tech-Medical Services operates in compliance with 21 CFR Part 820 (Quality Management System Regulations) and applicable distribution standards.
  • Logistics Integrity: We utilize vetted 3PL partners who adhere to Good Distribution Practices (GDP) to ensure the safety and efficacy of all surgical instruments.
  • Inventory Intelligence: Our proprietary technology ensures real-time tracking of expiration dates and lot numbers, preventing the distribution of non-conforming products.

Quality Management System

The Quality Management System is maintained to support operational consistency, regulatory alignment, and accountability across our activities.

  • Document control and records management
  • Supplier qualification and ongoing supplier monitoring
  • Incoming inspection and product acceptance activities where applicable
  • Complaint handling and feedback-driven improvement
  • Corrective and preventive action (CAPA) processes when required
  • Training and competency tracking
  • Traceability and retention of required quality records

Regulatory Framework

Tech-Medical Services, Inc. maintains a quality management system aligned with applicable U.S. Food and Drug Administration (FDA) requirements, including 21 CFR Part 820 (Quality Management System Regulation (QMSR)), which incorporates ISO 13485.

Our internal systems are structured to support regulatory expectations for documentation, risk management, and quality oversight.

Supplier and Partner Oversight

Critical suppliers and service providers are evaluated and managed through risk-based controls, written agreements where appropriate, and ongoing performance monitoring.

These oversight processes are designed to protect product quality, ensure continuity of supply, and safeguard customer experience.

Record Retention and Data Integrity

Quality records are maintained and retained in accordance with defined retention requirements and data integrity expectations.

When third-party facilities hold legacy records, documentation is reviewed for completeness and consistency prior to disposition decisions.

Regulatory Contact

Questions related to quality or regulatory topics:

Important: This page does not imply FDA approval of the company or its products. Regulatory status such as FDA clearance, where applicable, is stated only on individual product pages using accurate and specific regulatory language.