Regulatory Life Cycle

Regulatory Lifecycle for Medical Devices

Medical device definitions vary in different parts of the world as well as classifications and required activities. Therefore, it is beneficial to consider your target markets in the regulatory plan(s) to strategize activities allowing a smooth global registrations process and reducing the time to market. If you plan on entering the US market, followed by the EU and Australia, it is worth qualifying and classifying your product in all planned markets. This is applicable especially if it looks like the device is not a medical device in your initial target market, but it might be somewhere else. It may affect heavily on the development activities.

General Documentation Process

At the start, we identify your product requirements and risks. We then cover the entire design process from development to design control of the manufacturing company.

After the defining phase, a prototype is made, tested and transferred to production. Each of these steps contains a significant amount of documentation ie evidence, including specifications, test plans and reports, work instructions and device technical documentation. A significant part of the evidence for compliance is the clinical evidence. This starts with clinical evaluation which often needs to be supported by a pre-market clinical investigation.

Regulatory lifecycle

After CE marking, FDA clearance or other local (sales) approval, the manufacturer must maintain technical documentation, and inform changes to authorities where mandatory. We have experts to monitor regulatory landscape changes and perform the activities needed to keep medical devices in the desired markets, including post-market surveillance as a service (PMSaaS). Most of the markets require active post-market surveillance and reporting to authorities, which depends on the risk level.