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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BAAT Medical Manage your supply chain
BAAT Medical Develop your product
BAAT Medical monitor patient safety
BAAT Medical Bear legal responsibility
BAAT Medical - From medical idea to market success
Assure compliance to MDR - FDA

Manage your supply chain

At Baat Medical, seamless supply chain management is crucial after your product hits the market. We handle order processing, timely deliveries, and engineering change orders with precision. Our operational services are designed to sustain and enhance your product’s market presence. Trust in our comprehensive approach for continuous clinical follow-up and supply chain excellence.

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Develop your product

At BAAT Medical, our journey to market readiness is defined by a controlled, transparent process. We integrate design, engineering, and risk management with rigorous verification and validation. Selecting the finest in the supply chain and ensuring comprehensive user information, we uphold the highest standards of clinical evaluation. Our meticulous technical documentation and a robust Device Master Record (DMR) affirm our compliance with MDR and FDA regulations, setting the stage for your device’s success.

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Monitor patient safety

Clinical evidence is more important than ever. We can create your Clinical Evaluation Report and assist setting up clinical trials in US and EU. And after market introduction we keep your technical file up to date with PMS and PSUR.

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Bear legal responsibility

How to organize the formal responsibility of being legal manufacturer? And how to keep your device on the market and manage the life cycle of your device? We can be your legal manufacturer while you hold your identity and IP.

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Define your business

At BAAT Medical, we guide you in looking ahead to a prosperous future. Together, we will identify key stakeholders, assess external factors, and craft a compelling business case. Our 20+ years of experience in the medical device sector ensures that your journey from concept to market is both visionary and grounded, setting clear milestones and budgets. Partner with us to define and refine your business strategy, leveraging our deep industry knowledge for your success.

Contact us today

Assure compliance to MDR / FDA

Use the BAAT Quality Management System to accelerate your time to market during development and setting up your supply chain and after launch for your life cycle management. Our Quality Management System is always updated for MDR and FDA regulations.

Contact us today

At Baat Medical, seamless supply chain management is crucial after your product hits the market. We handle order processing, timely deliveries, and engineering change orders with precision. Our operational services are designed to sustain and enhance your product’s market presence. Trust in our comprehensive approach for continuous clinical follow-up and supply chain excellence.

Contact us today

At BAAT Medical, our journey to market readiness is defined by a controlled, transparent process. We integrate design, engineering, and risk management with rigorous verification and validation. Selecting the finest in the supply chain and ensuring comprehensive user information, we uphold the highest standards of clinical evaluation. Our meticulous technical documentation and a robust Device Master Record (DMR) affirm our compliance with MDR and FDA regulations, setting the stage for your device’s success.

Contact us today

Clinical evidence is more important than ever. We can create your Clinical Evaluation Report and assist setting up clinical trials in US and EU. And after market introduction we keep your technical file up to date with PMS and PSUR.

Contact us today

How to organize the formal responsibility of being legal manufacturer? And how to keep your device on the market and manage the life cycle of your device? We can be your legal manufacturer while you hold your identity and IP.

Contact us today

At BAAT Medical, we guide you in looking ahead to a prosperous future. Together, we will identify key stakeholders, assess external factors, and craft a compelling business case. Our 20+ years of experience in the medical device sector ensures that your journey from concept to market is both visionary and grounded, setting clear milestones and budgets. Partner with us to define and refine your business strategy, leveraging our deep industry knowledge for your success.

Contact us today

Use the BAAT Quality Management System to accelerate your time to market during development and setting up your supply chain and after launch for your life cycle management. Our Quality Management System is always updated for MDR and FDA regulations.

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).

  • 25+ experts on all disciplines
  • 30+ products to market
  • Both EU and US markets product launches
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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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