Greenlight Guru Clinical Webinars for Medical Device Professionals

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Alternatives to PMCF Clinical Investigations

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 Greenlight Guru Clinical 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.

alternative to PMCF clinical investigations

How to Use Clinical Data for Medical Device Submissions in both

In this free webinar medical device experts from Avania and Greenlight Guru Clinical 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?

best practices for data structure in medical device studies

Best Practices for Structuring Clinical Data in Medical Device Studies

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.

best practices for data structure in medical device studies

Key Pitfalls to Avoid in MedTech Clinical Data Collection

With 10 years of experience in the MedTech field, clinical data experts and co-founders of Greenlight Guru Clinical, 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.

most common pitfalls in clinical data collection webinar

Integrating Connected Device Data Into Your Clinical Study

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 Greenlight Guru Clinical's, Jón Bergsteinsson and Adam Steadman, provide key insights on best practices for how to integrate device data into your clinical study.

econsent in medial device clinical studies

How to use eConsent Efficiently in Medical Device Studies

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, Greenlight Guru Clinical's Adam Steadman, and CEO, Páll Jóhannesson, present key insights on what when, how and why you should use eConsent in your study.

econsent in medial device clinical studies

How to Collect PMCF Data for Lower Class Devices & WETs

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, Greenlight Guru Clinical'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.

SMART-TRIAL Product Series Webinars

Greenlight Guru Clinical 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