The jungle of rules and regulations in medical device business – is it a nightmare or a fairy tale?

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The design and manufacturing of medical devices is way more challenging than engineering work and factory production of e.g. consumer electronics. 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. In addition to following certain criteria, the companies must also be able to verify that they operate according to them.


The jungle of rules and regulations


The above mentioned “criteria” includes e.g. the quality management system (QMS), which is “must have” for every medical device manufacturer. It covers processes related to the medical device’s development, manufacturing and maintenance throughout its whole life cycle. In addition to QMS, the regulatory requirements concerning medical devices are compelling. For example, EU’s medical device directive describes how a manufacturer of medical devices has to operate. The operation is also regulated by other region and country-specific laws and legislations, such as FDA, that apply to manufacturers who export their products to the American market. The regulatory requirements are very strict and complicated - both in Finland and in international markets.

The regulatory approvals granted by the regulatory authorities are a necessary prerequisite to achieving the market authorization for the device. This must always happen even before the device can be manufactured and subsequently sold in various markets and countries; the authorities must exercise constant vigilance so that the safety and effectiveness of the device are ensured and verified before companies launch their devices to the market.


Just knowing the regulations is not enough


Well, one could say that taking all the national and international quality and other regulations into consideration is time-consuming. - Yes, it is, and it requires considerable expertise as well. And, in addition to knowing the regulations, companies have to be able to implement them in practice as well - to ensure the safety and effectiveness of medical devices, the regulations have to be taken into account throughout the entire medical device life cycle. 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 to follow the regulations related to each phase.

In other words: 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! And that’s why someone could say that bringing a medical device or an IVD device to market can be a nightmare. It’s often narrated as demanding process full of confusing regulatory standards and regulatory authority certifications that must be complied with and which must be integrated into the design and production of the device.


Build the quality into the daily work and operation


But is it really a total nightmare? We’ve experienced that it is not if you recognize “the best practices” in ensuring the quality compliance of your medical device. One way to ensure an expedited path from the original idea to the final market launch, and to turn the process to feel a little more fairy tale than a nightmare, is to build the quality 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 – which at the same time smoothens the process as a whole as well as speeds-up the time to market launch.

But what kind of requirements we need to meet during different stages of the medical device life cycle – how is the medical and IVD device regulatory process like in practice? To answer that, we've now created a free package for you including insights on how to ensure the quality compliance of medical devices throughout the whole medical device life cycle. It shows an illustrated outline of the stages in developing your idea into a worldwide selling product in the medtech/healthtech sector. Please download your free white paper below!

how to ensure the quality compliance of your medical product 

Picture of Elina Ihme
Written by Elina Ihme
Head of Marketing and Communications
Blog, Quality & Regulatory Affairs