Master the quality and regulations of you medical device

Ensure the quality and regulatory compliance of your medical device throughout the whole medical device life cycle!

Bringing a medical device to market is full of regulatory standards and regulatory authority certification that must be complied with and which must be integrated into the design and production of the device. In the medical device business, it is not enough to have just a good end-product; the development and production processes also have to fulfill very demanding criteria.

Every company working in the field must commit to ensure that high quality and regulatory requirements are met throughout the device whole life cycle. This requires deep understanding and knowledge of continuously changing regulations and standards.

But why is it so? Why are rules and regulations needed in medical business, and why is it that important to follow and meet them? And what kind of requirements we need to meet during different stages of the medical device life cycle – how is the medical device regulatory process like in practice?

In this page you will find some insights on how to ensure the quality compliance of medical devices throughout the whole medical device life cycle efficiently.

The following topics are addresses in this page:

  • The role of rules and regulations in medical business
  • Domain specific features – what need to be recognized?
  • Medical and IVD device regulatory process in practice

The role of rules and regulations in medical business

The design and manufacturing of medical devices is way more challenging than engineering work and factory production of e.g. consumer electronics. To ensure the safety and effectiveness of medical devices the regulations have to be taken into account throughout the entire medical device life cycle. It is mandatory to know and follow the regulations related to each life cycle phase of the product.

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: the rules and regulations define how we in medical business operate, every single day.

Quality throughout the whole lifecycle

Reasons – why are rules and regulations needed in medical business?

Bringing medical device to the market is 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. Because of the burdensome regulations in the field, someone could say that bringing a medical device to market can be a nightmare. This is something we discussed about in our earlier blog post, as well.

But there really is quite simple and practical reasons for that why are rules and regulations even needed in medical business, and why it is that important to follow and meet them.

The top three reasons are:

To get market access
–> If you won’t meet the standards and the regulations you’re not able to enter the certain market you’re trying to enter in

To ensure safety and effectiveness of the devices
–> The main purpose of enforcing standards and regulations in the medtech sector is to protect both the patients and the users by ensuring the safety and effectiveness of the devices

To avoid patient injuries or even deaths
–> If things go wrong, the device can cause patient injury or even death
–> If things go better, the device can save peoples’ lives

More discussion about WHYs? Please read more from Innokas Business Blog by following this link!

Domain specific features – what need to be recognized?

As discussed earlier, it is not enough to have just a good end-product in medical business – the development and production processes also have to fulfill certain criteria.

This “certain criteria” that companies need to follow includes e.g. the quality management system (QMS), which is “must have” for every medical device manufacturer. QMS covers processes related to the medical device’s development, manufacturing and maintenance throughout its whole life cycle.

The QMS can be seen to be one key to ensure the success in the market. The well-established quality management system helps the companies to comply with current regulations as it establishes the company processes in a way that those align with regulatory expectations and standards.

We suggest you to partner with some professional in the field that can help you to proceed with all Quality and Regulatory actions; e.g., who can create and maintain certified QMS which is based on your own operation at the very practical level. Alternatively, you can outsource the design and/or manufacturing to a partner company who has the QMS in place and have only other functions covered in your QMS.

Read more about QMS as a key to your success from here!

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. In EU, the new Medical Device Regulations (2017/745/EU) (MDR) will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD).

The new rules will apply after a transitional period, which will come to its end on 26th May, 2020. From that date on the new MDR will apply fully. Due to the changes in the medical device legislation in the EU, there’s a lot of things you need to know as a medical device manufacturer. That’s why we’ve started a blog post series, where we discuss about the new MDR and its effects.


Read more from about the new MDR and its effects!

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. More tips for medical device companies for US market entry from here.

The regulatory requirements are very strict and complicated – both in Finland and in international markets. If you find it too difficult to handle them by yourself, we suggest you to partner with some professional in the field that can help you to proceed with all Quality and Regulatory actions.

Ensure the quality compliance of your medical device – learn about the regulatory process in practice

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 in practice.

The rule number one is to 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.

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. 

how to ensure the quality compliance of your medical product

Key to success

You should make sure that your company and your cooperation partners are committed to ensure that high quality and regulatory requirements are met throughout the device whole life cycle. Just as the end users as well as the authorities require.

Do you want to hear more or discuss with our professionals? Let’s talk! Click here to leave us your message, and we will get back to you shortly!