SMART-TRIAL Webinars

Most recent webinars from SMART-TRIAL

Get answers on PMCF Surveys in this Live Q&A Session

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.

Many clinical teams are left with open questions like:
  • How can a survey comply with Annex XIV (B) of the EU MDR?
  • How can a survey comply with ISO14155?
  • What market access data should clinical teams include in clinical investigations?
  • How many people should I recruit (sample size)?

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.

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How to design your medical device trial to achieve market access success

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

Join our webinar and learn:
  • Which strategic questions should you be asking your stakeholders during early development, in order to achieve commercial product success?
  • How to ensure the clinical strategy is aligned with the overall value generation and value communication strategy?
  • What market access data should clinical teams include in clinical investigations?
  • How PMCF studies or other mandatory activities can be used for more than performance and safety documentation.
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How to Estimate Sample Size for Medical Device Studies?

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.

You will learn:
  • The basic inputs behind sample size estimation.
  • How study design can impact sample size.
  • How to prepare for a discussion on sample size with a statistician.
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Collecting Clinical Evidence in a Post-market setting - Three Success Stories

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.

Watch this presentation and get insights on:
  • What PMCF related activities Medical Device manufacturers are conducting?
  • Pitfalls of collecting Clinical Data and how to mitigate them.
  • Three success stories from manufacturers that have had success with implementing a post-market clinical data strategy
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What you should know when designing a PMCF plan for your Medical Device?

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.

Get insights on:
  • How your PMCF strategy can impact the rest of your portfolio
  • How ethics interplay with your PMCF plan
  • How to justify PMCF data results
  • How you demonstrate sufficient data quality
Watch the webinar
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