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Post-Market Clinical Follow-up (PMCF) is necessary for maintaining medical device regulatory compliance in the EU. PMCF Studies are commonly mentioned throughout the EU MDR and guidance documents.
But a PMCF Study does not always have to translate into an interventional or observational Clinical Investigation.
In this webinar, leading MedTech experts from QServe and SMART-TRIAL by Greenlight Guru will share their insights on alternatives to PMCF clinical investigations and suggest ways manufacturers can accommodate clinical data to comply with the PMCF requirements under the EU MDR.
In this free webinar medical device experts from Avania and SMART-TRIAL by Greenlight Guru will share advice and insights on how you optimize your clinical strategy for multiple markets and answer common questions, such as:
What type of parallel clinical evidence strategies could you consider when drafting a clinical development plan for multiple markets?
What are some of the local requirements for clinical investigations?
How can you optimize the study design to be useful for multiple clinical submissions?
Designing data collection plans for medical device studies can be cumbersome. One of the fundamental requirements of GCP and ISO 14155:2020 is to have a statistical analysis plan, together with eCRF and ePRO specifications.
But how do you ensure that clinical data is collected in line with your study goals while taking the clinical workflow at the study sites into account?
Watch this webinar to learn about best practices for structuring your clinical data from clinical experts Jón Bergsteinsson and Rasmus Blendal.
With 10 years of experience in the MedTech field, clinical data experts and co-founders of SMART-TRIAL, Páll Jóhannesson and Jón Bergsteinsson have noticed how time after time medical device companies are tripping over the same pitfalls. Therefore, Páll Jóhannesson and Jón Bergsteinsson have decided to share their insights on the most common pitfalls they have encountered to date, and how you can avoid them.
Watch the entire webinar right now on-demand, and hear also why the medical device industry should rely on unique solutions instead of mainstream EDCs that are generally used by pharma.
How do you handle a massive and continuous stream of device data, and what is required to acquire the data in a structured and GCP compliant manner?
Watch SMART-TRIAL CCOs', Jón Bergsteinsson (EMEA) and Adam Steadman (Americas), provide key insights on best practices for how to integrate device data into your clinical study.
The use of eConsent in medical device studies has been a topic of discussion in the medical device industry for years, and due to Covid-19, sponsors have been increasingly considering the feasibility of implementing eConsent in the clinical workflow.
But how do you use eConsent efficiently in your medical device study?
In this webinar, SMART-TRIAL's CCO - Americas & Asia, Adam Steadman, and CEO, Páll Jóhannesson, present key insights on what when, how and why you should use eConsent in your study.
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Designing PMCF activities for lower class medical devices and other well-established technologies can be a challenge.
Most users aren‘t interested in being involved in long or dreadful clinical investigations. So for those devices used on a day-to-day basis in clinical practice, we need to implement modern methods to gather data on clinical experience and safety.
In this webinar, SMART-TRIAL‘s PMCF expert, Jón Bergsteinsson, teams up with CEO of Evnia, Efstathios Vassiliadis, to present you with a simple, yet powerful tool, to collect real world clinical experience data to use in your PMCF report.
Watch the webinar to get key insights on PMCF data collection for WET and lower class devices.
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Join our product series webinars and get an expert tour of one or more of our products. We will give you insights on product features and benefits as well as go through interesting use cases for each product.
The age of paper has passed and eConsent is becoming an increasingly popular method to obtain informed consent in clinical investigations. The benefits of using eConsent in clinical investigations become clear to many companies as they replace outdated paper-processes.
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With the date of application for the MDR approaching fast, many are struggling to design a PMCF plan to pass the scrutiny of Notified Bodies. Because of the lack of guidance and experience on PMCF, determining design choices of a PMCF study, such as the sample size, can be a challenge.
To maximise resources and overcome new challenges brought on by the new MDR and IVDR requirements, clinical teams need to eliminate typical issues that can hinder a successful transition towards compliance.
A PMCF survey under the MDR is not like a traditional survey. As a sponsor, you need to ensure that the methods and data will pass the scrutiny of the Notified Bodies.
This live Q&A provides MedTech industry professionals with a chance to get actionable insights by getting their own questions answered and also derive inspiration from the questions asked by their peers.
VIEW THE SESSION
When developing medical devices, companies are prone to fixate on obtaining the obligatory CE mark or FDA approval. Many fail to identify the need to strategically plan their journey during the development lifecycle towards market access success
One of the first crucial steps in designing a clinical study is determining the number of subjects to recruit i.e the study sample size. To pass scrutiny from Notified Bodies on PMCF and clinical investigation plans, you have to justify sample size estimation with scientific reasoning. Even though the webinar will present statistical methods they will be explained in a simple and relatable way.
Planning and executing a successful post-market clinical data collection strategy is a challenge, and the lack of examples of how PMCF studies shall be conducted leaves many uneasy. The requirements for clinical evidence vary depending on the device type and classification, but “proactive” remains a keyword within the regulation.
The MDR is very clear on what a PMCF plan should include, but the choice of strategy can greatly vary from one device to another. If you are looking for guidance on your choice of strategy for your medical device PMCF plan, this webinar is for you.
