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Designing and developing medical devices is a complicated and interwoven set of processes.

Each step must be meticulously planned and carried out. It may appear to be a difficult task to make it a reality. You may be missing crucial information, resources, or personnel.

The optimum way to add essential functionality may be uncertain.

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How start the development of a medical device ?

Consider this scenario: You started developing a medical device, and once you’ve completed all of the tests and determined that it’s a good product, you’re ready to put it on the market. When regulators request your design paperwork, your mind goes into overdrive.

This article will discuss the bonus episode of the Medical Device made Easy Podcast. Stefan Bolleininger, a key opinion leader and speaker for the medical device regulation MDR in Europe, and Monir El Azzouzi, founder of the be-on-Quality GmBh consulting agency.

They will passionately support manufacturers during CE approvals or FDA approvals, explaining when you should focus on the development of your product prototype and when you should focus on your product documentation.

You can check the video below

Step 1 – Product Development

The medical device development process entails understanding and dealing with many issues—legal, financing, sales and marketing, intellectual property protection, liability protection, human resources, and more.

But here is one of the biggest challenges to starting: Coming up with a great and unique product or service.

Design and Development

As a result, the first step is as follows: If you have a startup that you want to pitch to investors and obtain funding, the first thing that you need is a product. So, it would be best if you plan the evolution of your product.

Consider your finance options and the markets you want to enter. In some ways, the concept and feasibility stage is crucial because it is during this phase that you will have a functional gadget to show your concept.

Set the ball in action only after you’re satisfied that your device has a viable market position, and is financially sustainable. You will require financing to prototype and test your product.

If you’ve made it to prototyping, you’ve completed Phase I and are ready to go on your trip. Congratulation!

But you should remember one thing. This journey that you are going on should be recorded somewhere because the Notified Bodies will ask you to describe this journey and the meeting minutes, test reports and others will be the proof that you’ve followed a certain path. Keep these documents with a date, a signature as they may be really helpful when you’ll go to phase 2.

Step 2 – Document Creation

Most developing businesses understand the importance of document control, especially in highly regulated areas like healthcare. It’s critical to understand the role of document control within a quality system if you want to develop a more robust system that handles numerous functions within your medical device.

Only then will you be able to put in place the methods that are exclusive to your product development. We all want to make medical devices safe and effective, meet all regulatory standards, and be commercialized quickly.

Pyramid Quality Management System documentation - Easy Medical Device

So, the second step is to have the documentation, even if it is not perfect. It will allow you to see the right way and direction and have a strategy. You’ve probably heard the phrase, “If it wasn’t documented, it didn’t happen.”

Nonetheless, it is correct. Every component and functional area of a medical device company relies on documentation.

Within your company, documentation can be used to collaborate and communicate. Documentation is crucial for establishing conformity to regulatory agencies and auditing organizations.

Electronic Quality Management System

We advise you to look for an eQMS which is software that will help you store your documentation in a compliant way and also be able to help you manage all the approvals of it. Notified Bodies really like that.

If you’re not sure where to begin or how to begin, you can check the link below and meet the highest of industry standards, without notice.

Scube Technologies is a company that is developing an eQMS dedicated to Medical Devices. So if you are within this industry, choosing this eQMS will help you gain time as this is really fit for you.

SmartEye Scube Technologies logo

Technical Documentation

In terms of documentation, you also need for some region to create a dossier that will be reviewed by the authorities. In Europe, this is the technical documentation. The content of this documentation is defined by the EU MDR 2017/745 and EU IVDR 2017/746.

If you want to know more about Medical Device Technical Documentation Please see the following website for more information:

What Is Important for Medical Device Design?

When creating medical devices, measuring and fulfilling user requirements will result in successful products that improve patient safety, device effectiveness and reduce product recalls and revisions. Medical device users are a broad demographic, with patients, carers, and a range of healthcare professionals potential users for any given device.

While patient safety and reducing human error are paramount, user requirements in medical devices should also include usability characteristics such as comfort, effectiveness, ease of use and learning, training, cleanliness requirements, maintainability and servicing, storage, labeling, etc. Patients’ willingness to stick to a treatment regimen can be influenced by factors such as comfort, attractiveness, and portability, especially with self-administered devices.

Design and development medical devices - Easy Medical Device

Understanding the intended usage is vital in developing a novel medical device. This would answer queries like who will be the product’s user. All is, of course, linked to the product concept and business potential. Not only for medical devices but any product development project, the intended application is good to start.

Podcast episode: Agile or Waterfall for design development

On this episode of the Medical Device made Easy podcast, Jon Speer from Greenlight Guru is explaining to us the different models that are used to design a Medical Device. And you’ll see the fight between Agile and Waterfall methods. Guess who wins?


To sum up, Medical device startups must have a product, all parts and pieces established, and executed by the time they go to market.

As soon as your device begins to take shape, ensure that you have your technical documentation for the market. Making a medical device can be financially rewarding while resolving complex day-to-day health issues.

The process should not be hastened since the authorities will be on the lookout for vigilance, compliance with legislation, and other requirements.

If you’ve followed the steps correctly, you’ll have a decent chance of successfully bringing a product to market.

Should you start with Product Development or Document Creation?
Article Name
Should you start with Product Development or Document Creation?
There is a challenge for Medical Device Development which is focus on product or on documents. This is what we'll try to explain.
Publisher Name
Easy Medical Device
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Categories: Europe

Monir El Azzouzi

Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. He proposes his consulting services so don't hesitate to contact him at or +41799036836 My objective is to share my knowledge and experience with the community of people working in the Medical Device field.

UK Representative from January 1st, 2021

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