ISO 13485:2016 Medical Devices Quality Management System (MDQMS)
ISO 13485:2016 outlines the requirements for a quality management system for organizations involved in designing, developing, manufacturing, distributing, and servicing medical devices. It ensures compliance with regulatory and customer requirements, fostering reliability and safety.
Scope and Application
- Applicable to organizations of all sizes involved in medical device life-cycle stages.
- Ensures regulatory compliance and quality control.
- Applies to medical devices and associated services.
Quality Management and Compliance
Organizations must maintain and control essential processes, ensuring product consistency. Regulatory requirements may allow for the exclusion of design controls if justified, with alternative approaches integrated into the quality management system.
Risk Management
Risk assessment follows ISO 14971 standards, integrating structured processes to identify, evaluate, and mitigate risks at all stages of product development and lifecycle.
Why Choose UFC for Certification?
- Experienced faculty providing expert training.
- Over 3,000 successful certifications.
- 24/7 support and industry-recognized credibility.
- Transparent pricing and no hidden charges.
- Nationwide presence and trusted reputation.
Assessment & Audit Approach
- Phase I: Adequacy assessment audit.
- Phase II: In-depth effectiveness assessment for certification recommendation.
- Internal auditing program ensuring compliance.
- Comprehensive risk analysis and corrective action verification.