The development of medical devices is one of the most tightly controlled and regulated environments in the world. Medical device compliance is of critical importance to diagnostic manufacturers - without it, the future of the product will be compromised and could even endanger patient health.
The breadth and depth of industry regulations presents a significant challenge to many organisations, and few understand the implications and requirements to bring medical devices and connected health solutions to market. Connected Diagnostics has the expertise in this arena to help guide manufacturers seamlessly through the regulatory process, including all relevant documentation and validation specifications. We are experts in IEC62304 and IEC82304 SDLCs, ISO14971 and ISO13485.
Medical device compliance is essential to guarantee patient safety, ensuring approval from relevant regulatory bodies and making sure future audits run smoothly.
Standards, such as ISO 13485, are reviewed regularly in order to respond to the latest practices, including changes in technology and regulatory requirements. Navigating the complexities of connectivity regulations and keeping abreast of changes requires continuous monitoring and a depth of knowledge that is daunting for many.
Our experienced team can alleviate the burden of medical compliance, guiding you through the implications of numerous regulations as well as advising on the standards that apply to a specific product.
As medical and communications standards and regulations are constantly evolving, it is sometimes difficult to keep ahead of the game and ensure compliance to the ever-changing regulatory field.
In order to future proof products and the manufacturer, Connected Diagnostics can offer training programmes to ensure your workforce can navigate the relevant standards and regulations in relation to forthcoming product development and enhancements. We can also offer supplementary or follow up programmes, ensuring you keep up to date with all the latest changes in our evolving and fast paced industry.
Documentation & Processes
Medical development projects require a large number of documents, with the typical project generating between 22 and 40 software-related documents alone. The task of creating these may seem daunting, but with the help of our experts, the creation of these necessary documents and processes can be hugely simplified. All documentation and processes created by our team will be compliant with the necessary regulatory standards.
Validation & Submissions
Navigating the validation and submissions process can seem as daunting as the regulations themselves. Connected Diagnostics simplifies the process, providing expert knowledge and advice to give you peace of mind and ensure the successful validation of your connected diagnostics or digital health systems.
Our validation experts will guide you through the process, helping you to understand what is needed for a successful submission. We can also provide resources to perform system and integration level validation for you, including creation of the necessary plans, test cases and reports.
In addition we can help our customers to perform successful verification of the various subsystems in the project. As with validation, we can create plans, test cases and test reports (and potentially incident reports) to speed up your V&V process and accelerate the submission path. As we are IEC62304 compliant, all the test cases are subject to Audit Trail, on which we will create a comprehensive report using our state of the art requirements and test management tools.