A Quality Management System (QMS) is the foundation of safety, reliability and compliance for Medical Devices and In Vitro Diagnostic solutions. It forms an essential part of product development and when done well can form the spine of all your business compliance requirements.
Our specialist, consultative service is dedicated to designing, building and implementing ISO 13485 compliant Quality Management Systems to support regulatory approval and international growth.
Starting with the fundamentals of ISO 13485, we’ll work with you every step of the way to develop everything from your Quality Policy to core policies and procedures – all set up in a platform of your choice.
Whether you’re starting from scratch or building on your existing documentation, our Regulatory Team will provide end-to-end support to ensure your QMS aligns with ISO 13485.
We can even align other International and Market Specific standards with your QMS such as:
We develop a comprehensive regulatory strategy for your product, balancing patient benefits, customer expectations, and regulatory demands. This forms the basis for product classification and market approval pathways, aligning seamlessly with your business strategy.
Creating a QMS tailored to your needs is crucial. We specialise in systems that not only meet the requirements of medical device companies but also support your processes, ensuring compliance with standards like ISO 13485, US CFR 820, QMSR, EU MDR, or MDSAP.
We’ll support you to apply best practice in medical device design and development to get the best out of your QMS, regardless of what stage you’re at. Our risk management expertise ensures regulatory compliance and risk mitigation throughout your product’s development journey.
We develop a comprehensive regulatory strategy for your product, balancing patient benefits, customer expectations, and regulatory demands. This forms the basis for product classification and market approval pathways, aligning seamlessly with your business strategy.
Creating a QMS tailored to your needs is crucial. We specialise in systems that not only meet the requirements of medical device companies but also support your processes, ensuring compliance with standards like ISO 13485, US CFR 820, QMSR, EU MDR, or MDSAP.
We’ll support you to apply best practice in medical device design and development to get the best out of your QMS, regardless of what stage you’re at. Our risk management expertise ensures regulatory compliance and risk mitigation throughout your product’s development journey.
Jonathan Serjeant
Managing Director Metadvice
Edmund Broadhead
8foldGovernance is our trusted regulatory partner. We have collaborated with the team since inception to launch of Ayla, your CST Assistant, working with them to develop our quality documentation, submit our documentation in line with UKCA and meet crucial information security and product safety standards necessary for the UK market. “
Simon Nielsen
Our expert team can handle the entire process of Regulatory approval from conception to product registration. Explore our complete Regulatory services offering below:
Access our free Blogs to learn more about Medical Device Regulations alongside our expert insights on International Standards and Artificial Intelligence.
Get ready to go on a smooth compliance journey with our expert guidance. Book a no-obligation discovery call with a member of our Regulatory team and get started today!
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