Site master file

Simplify Compliance with Our Comprehensive Country-Specific Site Master File Templates for Medical Devices

Introduction: In the medical device industry, creating a compliant Site Master File (SMF) is essential for navigating regulatory complexities, meeting international standards, and demonstrating quality. Our specialized SMF templates cover country-specific regulatory requirements, saving manufacturers valuable time and ensuring compliance in key markets like Europe, China, and the U.S. By providing structured, ready-to-use templates, we support medical device manufacturers in streamlining document preparation and presenting consistent, high-quality information to regulatory bodies.

Table of Contents for a Comprehensive SMF Template

General Information on the Manufacturer
Contact Information: Key contact details, including emergency contact, ensuring 24/7 availability in case of recalls.
Authorized Activities: Overview of licenses and authorized activities across markets, ensuring transparency for regulatory authorities.
Quality Management System of the Manufacturer
QMS Overview: Insight into the company’s quality management processes, certifications, and compliance with international standards.
Supplier Management: Details on auditing suppliers and maintaining a compliant supply chain, emphasizing quality control.
Personnel
Organization Structure: Clear organizational charts to illustrate the quality and regulatory hierarchy.
Employee Count and Expertise: Providing evidence of adequate staffing to ensure product safety and quality.
Premises and Equipment
Facilities Description: Short description covering production, warehousing, and laboratory facilities.
Equipment and Sanitation: Comprehensive list of critical equipment, including calibration and maintenance processes.
Documentation System
Document Control: Description of documentation procedures to maintain traceability and ensure compliance with regulatory standards.
Production
Product Types and Validation: Specifications for product types, process validation, and material management.
Hazardous Substances: Guidelines for managing sensitive or hazardous materials.
Quality Control
QC Activities: Summary of laboratory procedures and compliance with testing requirements, enhancing product safety and traceability.
Distribution, Complaints, Product Defects, and Recalls
Distribution Monitoring: Details on tracking distribution, managing complaints, and implementing recall procedures to maintain product integrity.
Internal Audit

Audit Protocol: Regular audit schedules to maintain compliance and ensure continuous improvement in quality systems.

Why Our Country-Specific Templates Are a Game Changer

Saves Time: Each template provides a clear, structured outline so you can focus on completing the content rather than formatting.
Enhances Compliance: With ready-to-use, region-specific fields, you reduce errors and meet regulatory standards quickly.
Provides Regulatory Confidence: Demonstrate professionalism with a polished, standardized SMF that meets the expectations of regulatory bodies worldwide.

How Our SMF Template Supports Specific Regulatory Requirements

Our templates are carefully tailored to meet country-specific requirements, covering crucial aspects like:

General Information: Address and emergency contact sections align with regulatory expectations in the EU, China, and U.S.
Quality Management System: Country-compliant QMS details, such as ISO certification references and quality risk management practices, to support regulatory audits.
Premises & Equipment: Section 4 covers detailed HVAC descriptions, cleanliness standards, and temperature control to meet the strict guidelines of agencies like the EU MDR and China NMPA.
Internal Audits: Robust audit practices aligned with quality management standards specific to each market.

Choose Our Templates for Faster, Accurate Compliance

Simplify the preparation process and ensure your SMF is aligned with both global standards and local regulations. With our templates, compliance is more achievable, and regulatory submissions are smoother.