Streamline regulatory compliance and time-to-market. ISO 13485 is the international quality management system (QMS) standard for medical devices. The standard has been designed to help organisations demonstrate that their products meet stringent industry regulations and support patient safety through a risk-based approach to the QMS, an enhanced focus on regulatory requirements, and increased controls over suppliers. It applies to both organisations that manufacture devices and those that support device manufacturers, enabling them to optimize their processes and streamline product development lifecycles.
Our ISO 13485 services
LRQA provides training, certification, and assessment services in accordance with ISO 13485 requirements. Delivered on-site, remotely, or through a blend of the two, our flexible services can be tailored to meet your business’s unique needs.
Training
Build an understanding of QMS fundamentals with our range of training courses that have been designed for varying levels of experience and learning styles.
Gap analysis
An optional service where an LRQA auditor will work with you to identify any non-conformities in your existing QMS prior to your ISO 13485 audit.
Certification
Our certification process validates your QMS according to ISO 13485 and then assesses its effectiveness to demonstrate its capabilities, helping you to build trust with stakeholders.
Integrated audit
Integrating your QMS enables you to benefit from a more efficient and cost-effective integrated audit and surveillance program covering several functional areas.
Why work with us?
Global capability
LRQA has a global network of qualified auditors. This means we’re everywhere you are, putting us in a position to provide a local service with a globally consistent approach and dedication to excellence in assurance. Our people are true technical experts with in-depth knowledge of quality management.
Flexible delivery
Our ISO 13485 training and certification services can be tailored according to the needs of your business and can be delivered on-site or remotely, or via a blended approach. If you opt for the latter, you’ll receive the same high-quality service with the added benefits of flexibility and fast delivery.
History of firsts
We were the first to receive UKAS accreditation to deliver certification services for a range of standards across the globe. We continue to be instrumental in developing a variety of specific standards and frameworks across different sectors.
Total assurance
Our service doesn’t stop at compliance. LRQA experts are true specialists who work to add value through an effective and robust audit of your system.
Are you already certified to ISO 13485 and would like to transfer?
If you hold a valid accredited certificate of approval with another provider and you are considering moving, transferring your ISO 13485 certification to LRQA is simple. We'll work with you to ensure your transfer is as smooth as possible.
Interested in finding out how we can help your organisation?
CASE STUDIES
Who we work with
We help businesses across dozens of sectors push forward and achieve like never before. How can we help you?
INSIGHTS
What we think
LRQA's experts regularly share their research and insights.
Artificial Intelligence in Safety: pitfalls to look out for
