SMART-TRIAL Webinars for Medical Device Professionals

Register to join upcoming live webinars or watch our most recent webinars on demand

How to Collect PMCF Data for WETs and Lower Class Devices

In this webinar, SMART-TRIAL‘s PMCF expert, Jón Bergsteinsson, will team 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.

SMART-TRIAL Product Series Webinars

SMART-TRIAL Product Series Webinars

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.

SMART-TRIAL Product Series Webinars

Best Practices for eConsent in Medical Device Clinical Investigations

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 The benefits of using eConsent in clinical investigations become clear to many companies as they replace outdated paper-processes.

Watch the webinar and learn:
  • Best practices for eConsent in clinical investigations
  • The three ways of obtaining eConsent
  • GDPR compliance pitfalls when implementing eConsent
  • Answers to the most frequently asked questions about eConsent
eConsent in Medical Device Clinincal Investigations

Determining the Appropriate Sample Size for Post-Market Studies

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.

Watch the webinar and learn:
  • The importance of sample size justification for your PMCF plan
  • What determines a study sample size
  • The basics of calculating an appropriate sample size

How to Prevent Common Pitfalls in Medical Device Studies

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.

Watch the webinar and learn:
  • Why is it important to get the sample size right,
    and how to do it
  • Myths about GDPR. Are you missing out on
    vital data?
  • How do you ensure that you are collecting the right data for your PMCF plan?

Get answers on PMCF Surveys in this 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.


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.

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.

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

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