As a medical device manufacturer and as a medical device startup, your responsibilities don’t end when your orthopedic or other medical device product innovation launches on the market. In the EU for example, you must keep an eye on the product for as long as it is on the market according to various (MDR) regulations.
You have a great innovation for a medical device. Now, what are the first steps to take apart from getting investors on board and raise funding? Think about realising post market surveillance (PMCF) from the project start and the feasibility of commercial succes greatly improves. BAAT has the experience and know-how to manage and service all requirements that medical startups encounter. This includes the manufacturing route, CE/FDA application but PMCF as well. You focus on marketing and sales (and getting investors on board) and let us take away the pains that come with ensuring traceability of medical device innovations. Get ready for launch without headaches and hurdles that will come your way. Read all about do’s and don’ts concerning (post) market surveillance and feel free to contact us to get more info on how to move your project forward sustainably.
When a medical device enters the market, the post market surveillance or pmfc plan comes into action. Usually, this includes regular assessment of sales numbers, customer feedback, complaints, incidents and tracking of new/revised laws, regulations and standards. Risk management, Clinical evaluation, technical documentation and the PMS plan are updated with this new information to keep the technical file state of art. In addition, a post market clinical follow up evaluates the safety and performance of the device. Based on this, the manufacturer regularly confirms that the risk-benefit profile of the medical device is favourable and the product can continue to improve the lives of patients.
From idea-to-market medical device to deliver your device to end-users worldwide. This is what we do on a daily basis. With our Development you get all services integrated into a proven system so that you get the confidence to launch and deliver your device within your milestones:
How to turn your idea into a tangible device? Which suppliers to select that best fit your market? We know how to select and qualify medical device suppliers so let’s choose the ones that best fit your device and market. We setup and manage supply chains worldwide and we can do this for you too so you can focus on what drives you most; if that is technology development, sales and marketing or something else. Let’s manufacturing your device and relief you from:
Demonstrating safety and efficacy is critical to your medical device’s success both before and after market approval. We cover all medical device testing areas such as, but not limited to:
Are you looking for an external expert or do you prefer to place an expert consultant in your company? We are here for you. Our experts cover all relevant medical device topics such as, but not limited to:
How to get ISO 13485 complicance? Which regulatory route to take? Which coating to select? And all other questions that you might have related to your medical device. From beginner courses to refresher trainings and customized courses. Your education is our top priority in our trainings solution. Our trainings cover all topics related to medical devices as we provide:
From idea-to-market medical device to deliver your device to end-users worldwide. This is what we do on a daily basis. With our Development you get all services integrated into a proven system so that you get the confidence to launch and deliver your device within your milestones:
How to turn your idea into a tangible device? Which suppliers to select that best fit your market? We know how to select and qualify medical device suppliers so let’s choose the ones that best fit your device and market. We setup and manage supply chains worldwide and we can do this for you too so you can focus on what drives you most; if that is technology development, sales and marketing or something else. Let’s manufacturing your device and relief you from:
Demonstrating safety and efficacy is critical to your medical device’s success both before and after market approval. We cover all medical device testing areas such as, but not limited to:
Are you looking for an external expert or do you prefer to place an expert consultant in your company? We are here for you. Our experts cover all relevant medical device topics such as, but not limited to:
How to get ISO 13485 complicance? Which regulatory route to take? Which coating to select? And all other questions that you might have related to your medical device. From beginner courses to refresher trainings and customized courses. Your education is our top priority in our trainings solution. Our trainings cover all topics related to medical devices as we provide:
Post market clinical follow up is part of the post market surveillance process, specifically the part that keeps the clinical safety and performance profile of a medical device up to date. Like the post market surveillance, it already starts with a post market surveillance plan (PMCF plan) in the development phase. The goals of a medical device PMCF are to:
The post market clinical follow up plan describes when, where and how to systematically gather information to address these topics.
Once the medical device is being used, the activities in the plan are executed. Our clinical research experts dive into registers, perform critical literature reviews, and assess user feedback. Depending on the risks and unknowns of the device, the PMCF can include post market registry studies and/or post-market clinical investigations with the medical device.
The results are used in the post market surveillance to assess the risk-benefit profile of the medical device and confirm that you can continue selling it. Risk management, Clinical evaluation, technical documentation and the PMS plan are updated with this new information to keep the technical file state of art.
The results and conclusion of the post market surveillance are written down in a periodic safety update report (PSUR); this report is created periodically for the lifetime of the device. Depending on the classification of the device there is a requirement to add this to the technical documentation regularly, at least annually, or even to submit it at the notified body for review each year.
Paradigm Spine
The way BAAT Medical organizes projects and handles our requests is absolutely great. They have a structured approach that ensures everything runs smoothly and efficiently. One of the standout aspects is their ability to manage topics and make decisions internally, only seeking my input when absolutely necessary. This has not only saved me a tremendous amount of time but also instilled a great deal of confidence in their expertise and professionalism. I highly recommend BAAT Medical to anyone looking for a reliable and proficient partner.
Waldemar Link
The engineering services of Baat really complements our own design process, while seamlessly integrating into our existing operations.
Essity
Thanks to everyone at Baat medical involved in this project. We are very satisfied with your service (including performance, communication, and flexibility) and are looking forward to possible new collaborations.
EIT, a J&J company
Thanks to the close collaboration of our engineers with the BAAT team, we could execute our development strategy as planned. We couldn’t have reached this level of success without them.
Co-Founder & CMO InSpine
BAAT Medical is our reliable R&D partner in various projects. The project with EIT Cellular Titanium®️ medical development has been the cherry on the pie (so far)! Can't wait what next projects are going to bring us.
Belfry Medical GmbH
Successful products are not made only of great ideas; they require a good understanding of today’s and tomorrow’s market environment. The INNOVATE process was very insightful. It helped us define and decide what is necessary to fulfill all stakeholders’ present and future requirements in order to have a high-impact product and treatment. BAAT did a great job!
For implantable devices and class III devices, information about the safety and performance must be available to everybody. As legal manufacturer you must create a summary of safety and clinical performance (SSCP) and submit it to the notified body. The notified body reviews and uploads it in a publicly accessible database (Eudamed).
Discover your own potential and focus on entrepreneurship by outsourcing medical product engineering versus investing in organizing all activities, responsibilities and a quality management system in house.
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