Ensuring Excellence in Medical Device Quality Management Systems
ISO 13485:2016 is the international standard that sets out the requirements for a quality management system specific to the medical devices industry.
ISO 13485:2016 specifies requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard is designed to be used by organizations involved in the design, production, installation, and servicing of medical devices and related services. It can also be used by internal and external parties, including certification bodies, to help them with their auditing processes.
The standard is based on the process approach and incorporates the Plan-Do-Check-Act (PDCA) cycle, with risk management being a key component. It emphasizes the importance of regulatory compliance and the need to maintain the effectiveness of the quality management system.
Our team of ISO 13485 experts provides end-to-end support for your certification journey. We tailor our approach to your organization's specific needs, ensuring a smooth and efficient implementation process.
Comprehensive assessment of your current quality management system against ISO 13485:2016 requirements.
Development of all required documentation including quality manual, procedures, and work instructions.
Guidance through the implementation of processes and training of personnel.
Support during the certification audit and assistance with any non-conformities.
We provide comprehensive support to help you achieve and maintain ISO 13485:2016 certification
Our team consists of experienced professionals with extensive knowledge of medical device regulations and quality management systems.
We tailor our approach to meet the specific needs and challenges of your organization and industry sector.
We provide continuous support even after certification to ensure your QMS remains effective and compliant.