Regulatory Life Cycle

Regulatory Lifecycle for Medical Devices

Medical devices are regulated around the world. But as medical device definitions vary in different parts of the world as well as classifications, activities required may vary. Therefore it is beneficial to plan your target markets in the regulatory plan(s) to be able to plan activities better. This allows smooth global registrations and reduced time to market. So if you are planning a product for the US market and after that for the EU and Australia, it is worth qualifying and classifying your product in all of these planned target markets. This is applicable especially if it looks like the device is not a medical device in your initial target market, for example in the US, but it might be somewhere else. It may affect heavily on the development activities. Labquality has experience in various markets.

Design

There are several common aspects of technical documentation around the world. The most simplified pattern is:

The whole design process must be covered by the design and development (or design control) process of the manufacturing company. Their requirements and risks are identified in the first place to understand what user wants, and what are the requirements and related risks. This is similar everywhere. Although requirements and risks must include all the required aspects and the team thinking requirements and risks must have someone familiar with requirement and risk management processes, Labquality has those experts to support you. 

After defining phase, the product is designed, 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. Especially EU regulations have increased such requirements, thus clinical evidence must be solid. This starts with clinical evaluation which often needs to be supported by pre-market clinical investigation. Labquality can operate as your trusted CRO.

Regulatory lifecycle

After CE marking, FDA clearance or approval or other local sales approval, the manufacturer must maintain technical documentation, and inform changes to authorities where mandatory. Labquality has experts to monitor regulatory landscape changes and perform the activities needed to keep medical devices in the desired markets. Most of the markets require active post-market surveillance (depending on the risk level) and active reporting to authorities. Labquality provides also post-market surveillance as a service (PMSaaS). So keeping product on multiple markets simultaneously require some work and an organised mindset.