When you are working on a Quality and Regulatory Affairs department for a Medical Device company, there are some activities that can be difficult to handle. But when you have the right tools this can make your life easier.
The idea of this article is to propose you some tools that are really designed for a Medical Device company. I have tested them or participated in a Demo with the manufacturer and I challenged to owners related to some problems that I experienced in my career.
So let’s start with the first one
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This platform is available on the internet and will save you a lot of time if you need Regulatory Information.
When I was looking for the new Medical Device Regulation EU MDR 2017/745, I was as everyone heading to the EUROPA website where the regulation is available as PDF or Web text. But this was really plain text without explanation.
When Ivan Perez Chamorro, CEO of Medboardco.com contacted me. I was really skeptical about his tool. But after a few months of testing it, I cannot do any search without going to the platform.
The idea of Ivan is to help companies to save time finding Regulatory and Medical Devices information in a very simple, efficient, and visual way, with a vast collection of content in the platform and driven by their search engine and algorithm. Regarding visuals, they put some visual explanation of the regulation text in the EU MDR and IVDR. For example, when you read a chapter, an infographic is attached to help you understand the concept.
If you are reading some regulations, you see that they are linking to some other chapters or regulations. On Medboardco.com, there is a link available where you can directly access the information. No need to scroll anymore.
Podcast interview of Ivan Perez Chamorro
On my podcast episode, Ivan explained to use his entrepreneurial journey. It was my first interview on the podcast.
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The other information that is really important is the Regulatory Updates. When you need to perform your Management Review, there should be a part related to Regulatory updates. And I can tell you that this is sometimes a struggle to follow all the changes all over the world. Medboardco.com is now solving your problem by providing a list of all updates.
The platform is also providing so many other features, information, and data, it covers more than 60 countries, including countries summaries, standards, guidance, PMS data (FSCAs), definitions, requirements focus areas, experts content, and much more. Every quarter, the team is improving the tools and providing more value to the users.
If you want to test it, go to this link.
The promise of Meddevo is to digitalize your QA RA department by providing you the right tool for your Medical Device company. They will introduce to you the concept of eTD or Electronic Technical Documentation.
Imagine a tool that is really knowing all the regulatory requirements. And which alerts you when something is missing. This is really a dream tool.
The idea of Michael Kania, CEO of Meddevo, is to provide to any QA RA department an assistant to help them save time. This would be ideal for small companies that don’t have a lot of resources and really need to focus on what is most important.
Meddevo.com is designed specifically to fit the Medical Device requirements so don’t use it if you are a cosmetic or pharmaceutical company.
We always see some general tools and complain because they are not really understanding our business. Or, we need to buy different tools for different actions (Document control, training, complaints, CAPA, Audit…). With Meddevo, this is not needed anymore.
This tool has also an audit mode, which verifies if you have everything or if after an update something is missing.
If you are still using paper for your documents, or if you are using many tools that are not communicating together, I encourage you to test this tool and check if this can help you on your journey to put a compliant medical device on the market.
Podcast Episode with Michael Kania
Technical Documentation Templates
- Template compliant to requirements of MDR 2017/745 Annex II and III.
- Formatted with the chapters already defined.
- Guidance provided to help you identify the content to include
- General Safety and Performance Requirements compliant to Annex I.
- Include guidance to prove evidence to the requirements.
This tool is more for those that want to create a Quality System following a standard. On this case, I tested the tool for the creation of ISO 13485:2016 procedures and forms.
For that, I made a video with a challenge. Jason Lim, CEO of Stendard.io provided me full access to the tool so I will be in real condition. The objective for me was to create Quality documents within less than 30 minutes. I did put a clock and show you everything that happened on my screen.
This can be a solution for companies that just want to start with a basis. The documents are customized following your category of products, classification, company… So this is really an intermediate solution between buying a package of the templates that are really generic and hiring a consultant to build a custom-made system.
The tool is also evolving with more features to come as Workflow management for document change.
From the customer’s experience, this helped to reduce the time for certification to 3-6 months. Remember, that the document created is only one part of the Journey. I create an article with the 5 steps to get certified.
Podcast interview of Jason Lim
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In the case, you need to perform some Gap Assessment or need specific templates required for Medical Device companies. Regulatory Globe is building them for you.
The idea of Mickael Galiker, the CEO of Regulatory Globe, is to help medical device manufacturers to save time. This started with the EU MDR 2017/745 regulation when a gap assessment was needed to identify what are the actions a company should perform to be compliant with the new regulation.
Then this evolved to other standards and other requirements. These are essentially Excel documents that are completely built and which contains all the requirements you need to follow to be compliant.
As of today, you will find these templates available:
- Gap assessment EU MDR
- Gap assessment EU IVDR
- many others on the website
So if you are really trying to identify the gaps in your quality and regulatory affairs department, you need this tool.
I am really impressed by Greenlight.guru and the culture they are providing. This is really a company that is supporting a lot the Medical Device community. You should visit the website with a lot of resources, the podcast with great updates. So yeah, the company is great.
Now regarding the software they are proposing, this is also a solution dedicated to Medical Device companies. As Jon Speer, the Founder of Greenlight.guru is a Product Development geek as he always tells, the product is really designed to provide all the support needed for new product development.
Additionally, many Medical Device quality tools are available. And the magic is the fact that they are talking together. So you can link some solutions. I am used to working with companies that acquire different tools for a different part of the quality system which makes the life really difficult to the user.
I would maybe compare this software with the one of Meddevo that we discussed earlier but from what I saw during the demo, there are some differences as this one is not focused on the MDR requirements. But I am sure this will be included in the next updates.
Recently Cognidox released a deep dive review on Greenlight Guru software. It is an interesting one to read.
SimplerQMS
I had the opportunity to test the tool SimplerQMS and this was really interesting.
This is an eQMS that is helping you with your Quality Management System. It takes care of your Documents through the Document Control module.
It also manage your Suppliers, CAPA, Complaints, Technical Files, Product documents…
This is a complete solution for small and big manufacturers.
I have interviewed Jacob Sjorslev who is the CEO of SimplerQMS on 2 podcast episodes. We talked about the best way to implement an eQMS for your company and then about the validation of an eQMS. Check that here.
You can contact Jacob and ask for a demonstration on my behalf. I am sure it will be a pleasure for him to help you with your eQMS project.
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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 info@easymedicaldevice.com or +41799036836
My objective is to share my knowledge and experience with the community of people working in the Medical Device field.
