Do you have an idea of a medical device? Or have you already started to develop your medical device? Do you want to enter, e.g., EU or US markets?
If you answered yes, there is one very important matter you should be aware of: the medical device regulatory process! The good news is that actually right now, you’re reading a very useful blog post. Through this post and our White Paper you’ll get a great overview about the topic, and you’ll learn a little more about the regulatory process of medical devices in practice.
Rules and regulations – there are many of them
One very basic rule is that in medical device business, it is not enough to have just a good end-product - the development and production processes also have to fulfill certain criteria. Therefore, bringing a medical device to market can feel a nightmare. The process is full of confusing regulatory standards and regulatory authority certification that must complied with and which must be integrated into the design and production of the device.
Standards and regulatory requirements are very strict, complicated and controlled, both in Finland and in international markets. Taking all the national and international quality and other regulations into consideration is time-consuming – and it requires considerable expertise.
In addition to knowing all the regulations, companies have to be able to follow them, to implement them in practice and to verify that they operate according to them, as well.
Know and follow the regulations related to each life cycle phase
Already from the get-go, companies should change their mindset to life cycle thinking. Companies should understand that taking care of the regulations only at some life cycle phase of the product is not enough; in order to ensure the safety and effectiveness of the medical device, the regulations have to be taken into account through the entire product life cycle. If you won’t meet the regulations related to each phase, you’re not able to enter the certain market you’re trying to enter in! The aim is to follow and fulfill all the requirements and standards specified for the device.
Therefore, already from the very early product specification and component selection phase to sales approvals, production processes, supplier control and even after-sales services, it is mandatory to know and follow the regulations related to each phase. The documentation also needs to be done to the highest quality and have proven traceability.
Ensuring quality compliance: medical device regulatory process in practice
Based on our 20+ years of experience we’d say that to ensure an expedited path from the original idea to the final market launch, quality should be built into the company’s internal processes right from the get-go. Through such fine-tuned, high-quality processes companies can ensure that all the regulatory requirements are met during each phase from the idea to production and post production activities – at the same time speeding-up the time to market launch.
The following is an outline of the stages in developing your idea into a worldwide selling product in the medtech / healthtech sector. These phases demonstrate how to ensure the quality compliance to enable medical devices to be placed on the market as smoothly as possible.
The rule number one is to start the balancing early enough! Medical device developers should remember that the identification of the regulatory requirements begins already when you come up with the new idea. Every medical device developer must have a suitable Quality Management System (QMS) as well – and the QMS efforts need to be started already right after the idea phase, because it need to be in place already during product development.
In addition to QMS, there is a lot more that need to be recognized and fulfilled at the design and development phase of the device. Companies should remember that there is both process and device related standards which must be taken into account in the design and developing phase. The device must satisfy all the criteria if the development is to proceed.
Market approvals for different market areas are naturally needed – there are many of them, as well, and companies must apply those depending on the market areas the company tries to reach. This must always happen before the device can be placed on the market.
And there’s much more that must be fulfilled even before manufacturing: e.g., the design transfer as well as production process validation phases have their own requirements, as well. And when the manufacturing starts, the device need to be built according to the relevant standards and requirements throughout the entire production process. When manufacturing, you have to control that the design changes to the product are adequately transferred to production.
And because the life of a medical device does not end when it is sold to a customer, there are rules for post production phase, as well. The regulations require post-production activities to generate different kind of information regarding the use of the device.
To get even more detailed overview and description about the requirements the companies must meet during different stages of the medical device life cycle, please collect your free copy of our White Paper below!
The white paper shows the same, illustrated outline of the stages in developing your idea into a worldwide selling product in the medtech/healthtech sector – including more specific details what kind of actions, regulations and standards are required during each phase. Please download your free White Paper below!