Medical Devices Quality Management Systems Certification
In the medical device industry, quality and patient safety are non-negotiable. ISO 13485:2016 provides a globally recognised framework for organisations involved in the design, production, installation, and servicing of medical devices. By adopting this standard, companies demonstrate their commitment to meeting both customer expectations and stringent regulatory requirements across international markets.
At Veridix Consulting, we guide organisations through the entire ISO 13485 process—helping you build robust quality systems, prepare for audits, and maintain compliance efficiently.
ISO 13485:2016 is an international standard for Quality Management Systems (QMS) specific to the medical devices sector. It aligns closely with regulatory requirements such as the EU MDR (Medical Device Regulation) and FDA 21 CFR Part 820.
Key aspects include:
Risk-based approach for medical device development and manufacturing
Strong focus on regulatory compliance and product traceability
Requirements for sterile manufacturing, validation, and post-market surveillance
Emphasis on maintaining effective documentation and records
Implementing ISO 13485:2016 brings a wide range of benefits:
ISO 13485 can be integrated with:
ISO 14971 – Risk Management for Medical Devices
ISO 9001 – Quality Management
ISO 27001 – Information Security for sensitive medical data
ISO 14001 / ISO 45001 – Environmental and occupational safety considerations
Manufacturers, suppliers, distributors, and service providers involved in any stage of a medical device’s life cycle benefit from certification.
While not always legally required, many countries and customers demand ISO 13485 certification for market entry and regulatory compliance.
ISO 13485 is tailored for the medical device industry with stricter regulatory and risk management requirements, while ISO 9001 is a more general quality standard.
Certification is valid for three years, with annual surveillance audits to ensure ongoing compliance.
Depending on the complexity of operations and current systems, it can take 6–12 months on average.
Yes, it integrates seamlessly with ISO 9001, ISO 14971, and ISO 27001 for holistic quality and risk management.
Maintaining rigorous documentation, meeting sterilisation requirements, and ensuring cross-departmental involvement are key challenges—but expert consultancy simplifies the process.
We offer in-depth industry knowledge, tailored solutions, employee training, and end-to-end guidance to ensure smooth certification and long-term compliance.
Evaluating your current system against ISO 13485 requirements
Creating policies, manuals, and SOPs aligned with the standard
Awareness, Internal Auditor, and implementation workshops for your team
Practical guidance to roll out QMS processes effectively
Mock audits and readiness checks before the certification body arrives
Helping you align ISO 13485 with other standards for efficiency
How Veridix Guides You
Gap analysis and roadmap creation
Drafting and aligning QMS documentation
Deploying processes with staff engagement
Training, mock audits, and management review
Assisting during external certification audits