Post market surveillance PMCF

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.

Post Market Surveillance PMCF schematic for medical devices

Post Market Surveillance

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.

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Manage your supply chain

In order for you to understand the supply chain needs, you’ll want to get curious about the complicated puzzle that is medical manufacturing. Get to control, trace and monitor all aspects you will encounter from production, packaging, sterilizing, storing, transport and inspection by outsourcing your supply chain and leveraging our network of trusted and verified suppliers. We let you be the master of logistics and supply and ensure all control and safety in the medical supply network.

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Develop your product

Our competent BAAT team will develop your product and manufacturing process and provide all documentation needed to get market approval. We have learned that development of a medical device is a dynamic process, that never follows a straight line from start to finish. We will provide you with the right input to decide on next steps in the process. This allows us to achieve the best results possible within the time and budget restrictions you have set.

Contact us today

Monitor patient safety

Ensuring Clinical Safety and Performance is paramount when developing and marketing a medical device, especially for the European market. We concentrate all our activities around one question: Does the expected benefit of your device, when following the intended use, outweigh the inherent risks? Our Clinical Specialists know how to answer this question in the most efficient way. They navigate this delicate process, define the optimal route for collection of Clinical Data to get market approval and to access clinical safety and performance throughout the complete lifecycle of your product.

Contact us today

Bear legal responsibility

To bring your innovation to the market include various legal liability issues, associated with being a (legal) ‘manufacturer’ as is directed by the MDR and FDA regulations. This has nothing to do with intellectual property, branding or ownership; it is the formal legal responsibility, that is directly linked with the entity that develops, manufactures and delivers a medical device for use to the market. At BAAT we know what it means to bear this responsibility because we are able to formally act as legal manufacturer on behalf of our customers. We can help you to identify and solve liability issues throughout the manufacturing chain, put the right insurance coverage in place and make sure that all quality agreements are properly connected.

Contact us today

Define your business

To ensure a successful collaboration, we strive to understand your goals and business opportunities and get clear how our services fit best in your journey. With our 20+ years of experience we understand the dynamics of getting an idea to the medical device market. We will help you formulate the right strategy for device development, manufacturing, regulatory affairs, safety questions, clinical trials and legal obligations to get your medical device approved in the EU and US. Together we define and refine the crucial steps to reach your milestones.

Contact us today

Assure compliance to MDR / FDA

You probably know that regulatory affairs is an important piece of your medical devices puzzle. Which rules apply for your project in order to get approval from FDA and MDR? You want to be fully covered and know about existing and upcoming changes in regulations. Be smart and do not go reinventing the wheel. Instead make use of our proved ISO 13485 certified Quality Management System. This system is specially built to assure compliance from approval throughout the complete lifecycle of your product. We designed our QMS to ensure a fluent transfer and be linked to you own processes easily.

Contact us today

In order for you to understand the supply chain needs, you’ll want to get curious about the complicated puzzle that is medical manufacturing. Get to control, trace and monitor all aspects you will encounter from production, packaging, sterilizing, storing, transport and inspection by outsourcing your supply chain and leveraging our network of trusted and verified suppliers. We let you be the master of logistics and supply and ensure all control and safety in the medical supply network.

Contact us today

Our competent BAAT team will develop your product and manufacturing process and provide all documentation needed to get market approval. We have learned that development of a medical device is a dynamic process, that never follows a straight line from start to finish. We will provide you with the right input to decide on next steps in the process. This allows us to achieve the best results possible within the time and budget restrictions you have set.

Contact us today

Ensuring Clinical Safety and Performance is paramount when developing and marketing a medical device, especially for the European market. We concentrate all our activities around one question: Does the expected benefit of your device, when following the intended use, outweigh the inherent risks? Our Clinical Specialists know how to answer this question in the most efficient way. They navigate this delicate process, define the optimal route for collection of Clinical Data to get market approval and to access clinical safety and performance throughout the complete lifecycle of your product.

Contact us today

To bring your innovation to the market include various legal liability issues, associated with being a (legal) ‘manufacturer’ as is directed by the MDR and FDA regulations. This has nothing to do with intellectual property, branding or ownership; it is the formal legal responsibility, that is directly linked with the entity that develops, manufactures and delivers a medical device for use to the market. At BAAT we know what it means to bear this responsibility because we are able to formally act as legal manufacturer on behalf of our customers. We can help you to identify and solve liability issues throughout the manufacturing chain, put the right insurance coverage in place and make sure that all quality agreements are properly connected.

Contact us today

To ensure a successful collaboration, we strive to understand your goals and business opportunities and get clear how our services fit best in your journey. With our 20+ years of experience we understand the dynamics of getting an idea to the medical device market. We will help you formulate the right strategy for device development, manufacturing, regulatory affairs, safety questions, clinical trials and legal obligations to get your medical device approved in the EU and US. Together we define and refine the crucial steps to reach your milestones.

Contact us today

You probably know that regulatory affairs is an important piece of your medical devices puzzle. Which rules apply for your project in order to get approval from FDA and MDR? You want to be fully covered and know about existing and upcoming changes in regulations. Be smart and do not go reinventing the wheel. Instead make use of our proved ISO 13485 certified Quality Management System. This system is specially built to assure compliance from approval throughout the complete lifecycle of your product. We designed our QMS to ensure a fluent transfer and be linked to you own processes easily.

Contact us today

Post Market Surveillance clinical follow up arthrosafe example

Post Market Clinical Follow up

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:

  • Confirm the safety and performance of the medical device
  • Identify unknown side-effects
  • Identify emerging risks
  • Identify systematic misuse and off-label use

Pmcf plan reporting

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.

Pmcf plan results

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.

Post Market Surveillance clinical follow up arthrosafe example

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Safety of Implantable Devices and Class III devices

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).

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