ISO 13485:2016 Quality Management System
Introduction
ISO 13485:2016 Quality Management System
We specialise in helping organisations implement and maintain ISO 13485:2016 Quality Management Systems (QMS) tailored for the Medical Device and In Vitro Diagnostics industry.
Achieving ISO 13485 certification is not just a regulatory requirement; it’s a testament to your commitment to quality and patient safety. Let us be your trusted partner on the journey to ISO 13485 compliance and beyond.
experience
Why Choose BaxMed for ISO 13485:2016 QMS?
Expertise
Our team consists of seasoned professionals with a wealth of experience in ISO 13485 compliance. We understand the nuances and intricacies of the standard, ensuring your QMS is not only compliant but also efficient and effective.
Customised Solutions
We recognise that every organisation is unique. Our approach is highly tailored to your specific needs, ensuring your ISO 13485:2016 QMS aligns with your organisation’s processes, objectives, and goals.
Global Perspective
ISO 13485 certification is internationally recognised. We keep you informed about the latest updates and requirements, ensuring your QMS is aligned with all global regulatory expectations including 21 CFR 820.
Services
Our Comprehensive ISO 13485:2016 QMS Services Include:
Gap Analysis: We start by conducting a thorough gap analysis to identify areas where your current quality management system aligns with ISO 13485 and areas that need improvement.
QMS Development: Our experts work closely with you to design and implement a tailored ISO 13485:2016 compliant QMS, including document control, risk management, and process validation.
Training and Education: We provide training to your team to ensure they understand the principles of ISO 13485 and are equipped to maintain and continuously improve the QMS.
Internal Audits: Regular internal audits are crucial to maintaining compliance. Our team conducts comprehensive internal audits to identify and address non-conformities promptly.
Certification Support: We assist you in preparing for ISO 13485 certification and surveillance audits, ensuring a smooth and successful certification process.
Continuous Improvement: Achieving ISO 13485 certification is just the beginning. We help you implement a culture of continuous improvement to enhance device quality and customer satisfaction.
Trusted
Partner with BaxMed for Quality Excellence
ISO 13485:2016 certification is a badge of honour for organisations in the Medical Device and In Vitro Diagnostics industry. It signifies your commitment to delivering safe and effective products while maintaining rigorous quality standards.
Choose BaxMed as your partner in achieving and maintaining ISO 13485:2016 certification. Contact us today to discuss how our ISO 13485:2016 Quality Management System service can empower your organisation to excel in quality, compliance, and patient safety. Together, we’ll build a strong foundation for your organisation’s success in the highly regulated healthcare market.
Contact
Get in touch
Contact us today to learn more about how BaxMed Regulatory Ltd can empower your organisation to thrive in a highly regulated environment. Together, we can turn regulatory and quality challenges into opportunities for growth and innovation.