medical devices
Thrive have achieved ISO 13485:2016 certification. We are committed to maintaining this international standard and providing our customers with the best service. You can be confident that our prototypes are designed, developed, and manufactured in an environment of quality and continuous improvement.
our quality management system
As an organisation we are focused on developing exceptional products, including physical and digital services for our clients and with our collaborators. Maintaining our quality management system in order to deliver on this is an essential priority for Thrive. Our Quality Management System (QMS) requires us to work within a framework of process, governance, risk and compliance best practice and we are committed to continuously improving our capabilities to ensure we are able to design increasingly innovative and impactful wearable technology products.
To bolster our QMS, we hold accreditations for two internationally recognised standards which also enable us to work on designing and developing consumer products generally (ISO 9001) and medical devices specifically (ISO 13485).
ISO 13485:(2016)
In addition to ISO 9001, this standard sets out the requirements for a quality management system specific to the medical devices industry. This allows us to work on designing and developing prototypes for your medical device project, or for a product which may later become a medical device. Because regulatory requirements are increasingly stringent throughout every step of a product’s lifecycle, this standard is specifically important to designers, manufacturers and distributors of medical devices.
Helping to control the consistent design, development, production, installation and delivery, as well as the disposal of medical devices, means that we are able to achieve medical device certification which ensures they are safe for their intended purpose.
good to know...
ISO 13485 is the QMS standard accepted as the basis for CE marking medical devices under European Directives and Regulations and UKCA marking medical devices under the UK MDR 2002. The US Food and Drug Administration is in the process of harmonising its medical device quality management system regulation, 21 CFR Part 820, with the ISO 13485 QMS standard.
ISO 9001:(2015)
This standard outlines the criteria for our overall quality management system, setting out a framework for us to exceed client expectations and increase the value of our projects. Using ISO 9001 helps ensure that our clients get a consistent high quality experience, where we use the best products and services.
we are committed to the seven quality principles
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Maintaining a customer focus and striving to exceed client expectations at every turn
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Improving and developing our capabilities and effectiveness
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Promoting collaboration and facilitating knowledge sharing
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Establishing responsibility and accountability in managing processes, risks, and monitoring and evaluating our performance
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Improving our process performance, organisational capabilities and customer satisfaction, focusing on root cause investigation, and preventative and corrective actions
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Championing evidence-based decision making, balanced with utilising the experience and intuition of our team
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Maintaining a well-managed supply chain that provides a stable flow of goods and services
wellness devices
Our accreditations offer you flexibility, meaning that you can work on a low-risk wellness device initially - defined as something that promotes a healthy lifestyle - if that is your preferred initial product release approach.
This could include for example, fitness trackers, apps and exercise equipment which have the potential to become certified medical devices down the line, either through clinical trials or versioning, which can then be intended to diagnose, treat, mitigate or prevent a disease.
peace of mind
In working alongside us, you can be assured that compliance with these regulations is embedded in our processes. One of the main benefits is a more reliable provision of products and services in the most cost-efficient and resource-efficient manner, preventing mistakes.
If you continue on to manufacture your device with Thrive, we can produce Design Validation units which serve to complete CE / UKCA marking and other regulatory compliance to close the loop on your medical device certification.
complete service
We can guide you through the complete wearable product development process, from innovation to mass production. A key aspect of this process is prototyping, and we can manage that process with you, as it is embedded in our QMS. This will take you from feasibility and system prototypes, through to form factor, concept and production prototypes. Documenting these processes efficiently and making learnings during development enables your confidence in the quality of your product to grow, and sets you up to achieve medical device certification if you choose.
medical wearable tech
According to the ISO guidelines, a medical device is an instrument, apparatus, implement, machine, or other similar article, that is intended for use in the diagnosis, prevention and treatment of disease or other medical conditions. Because of our team of experts, our network, and our project portfolio, coupled with our quality management system and associated accreditations, we are the leading wearable technology agency to work with on your wearable medical device project.