Understanding the core elements of Quality Management Systems
In today’s competitive marketplace, delivering high-quality products and services is essential for business success. A Quality Management System (QMS) is
An ISO 13485 Quality Management System is a comprehensive framework designed to ensure that medical devices consistently:
At its core, the goal of any QMS is to emphasise the systematic approach to identifying and mitigating risks associated with medical devices, while also striving to enhance product performance and overall patient outcomes.
Established quality management systems (QMS), such as ISO 13485, FDA regulations, and other international standards, serve as benchmarks for compliance and continuous improvement within the medical device industry.
Gap Analysis and Readiness Assessment
Comprehensive gap analyses to identify compliance shortfalls in manufacturers’ quality management systems
Customized Implementation Plan
Tailored implementation plans with specific tasks, timelines, and responsibilities for achieving ISO 13485 certification
Documentation Development
ISO 13485 documentation development and refinement, ensuring quality manuals, procedures, and records are comprehensive and clear
Training and Education
Training programs on ISO 13485 principles, standards interpretation, implementation best practices, and internal auditing techniques
Process Optimization
Process optimization to align with ISO 13485, enhancing quality controls, risk management, and continuous improvement mechanisms
Internal Auditing and Compliance Monitoring
Conduct internal audits to evaluate the effectiveness of quality management systems and prepare manufacturers for external ISO 13485 audits
Support During External Audits
Support with documentation preparation, auditor inquiries and navigating the audit process
Post-Implementation Support
Ongoing post-certification support, including periodic reviews, documentation updates, and assistance with regulatory changes to maintain ISO 13485 compliance.
Making sure our customers understand the type of information they need to generate to become compliant.
Removing the jargon and complexity to deliver projects that are value for money and nurture customer relationships.
Being exact, accurate and careful at all times, so we deliver professional documentation.
Advice, guidance, and holding our customer's hands throughout the process from start to finish.
Tracey Slater, Cormed
In today’s competitive marketplace, delivering high-quality products and services is essential for business success. A Quality Management System (QMS) is
In today’s fast-paced and highly competitive business environment, ensuring the quality of your Medical Device products and services is paramount.
The ISO 13485 standard was built around the structure of ISO 9001 which is a standard for Quality Management Systems
Here we look at the top 3 medical device quality failures recorded in history. Do you agree with our list?
Patient Guard Limited:
Lancaster House,
Amy Johnson Way,
Blackpool, Lancashire FY4 2RP
Patient Guard Europe UG:
Hauffstr. 41, 73765 Neuhausen,
Deutschland / Germany
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