September 3, 2022

[FREE WEBINAR] Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process

Click here to watch the recording of this webinar.

How do you determine which content applies to each classification? How do you address data insufficiency for a WET or Legacy device? In this webinar, our medical regulatory experts, Dr. Sarah Chavez and Stacie Beecham, answer these questions and outline how to ensure your regulatory strategy will adequately support the clinical evaluation specific to your device. 

Key Takeaways

  • How to address limited clinical and performance data
  • Learn how to adjust the Clinical Evaluation Plan to align with the regulatory strategy
  • Understand the concept of data sufficiency

Who Should Watch?

Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions.  

Who are the Panelists?

Dr. Sarah Chavez, Director of IVD & Scientific Writing Services 

Stacie Beecham, Principal Medical Writer 

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August 17, 2022

The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process: Key Strategies to Support Project Success 

Author: Criterion Edge Writers

Regulatory Affairs (RA) professionals are poised to play a key role in supporting the clinical or performance evaluation report (CER or PER) process. Regulatory Affairs is active throughout the entire process, from pre-project planning through scoping and kick-off, report writing, review and sign-off, and finally, submission to the notified body.

How Can Regulatory Affairs Assist in the Clinical and Performance Evaluation Report Process?

The CER and PER are highly complex reports—not just because of the large amount of data they contain, but because they must tell a complex story. Putting all the evidence together for a successful submission is a difficult task, but RA is strategically positioned to provide critically important support and guidance to the evaluation writing team.

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August 8, 2022

[FREE WEBINAR] Bridging the Gaps: Determining When Clinical Data is Necessary to Demonstrate Conformity with GSPRs 

Click here to watch the recording of this webinar.

What do I do if there is no data for my device? This is a concern we hear quite often from clients. MDR states that device groups may not require clinical investigations if sufficient clinical evidence exists, and the device meets specific criteria. In this webinar, we discuss the concept of data sufficiency. Specifically, we explain the differences between a well-established technology and a legacy device as defined by MDR and discuss strategies from both a regulatory and writer’s perspective. 

Key Takeaways

  • Learn what is deemed sufficient clinical data for certain device groups
  • Determine how to establish a legacy device as a ‘standard of care’ device
  • Understand the conformity assessment pathways for well-established technology devices

Who Should Watch?

Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions.  

Who are the Panelists?

Dr. Sarah Chavez, Director of IVD & Scientific Writing Services 

Stacie Beecham, Principal Medical Writer 

Sign up for future webinars here.


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July 14, 2022

Unpredictability of MDR a Major Theme at EU MedTech Forum 2022 

Author: Criterion Edge Writers

Concerns and frustration surrounding the implementation of Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) were voiced in early May at MedTech Europe’s 2022 Forum in Barcelona. Two notable sessions that discussed MDR and IVDR implementation were reportedly lively and filled to capacity. The chairs of these sessions, Marc Pierre Möll, CEO of BVMed, and Oliver Bisazza, MedTech Europe’s Director General of Industrial Policies and External Affairs, shared their reflections on these discussions in Barcelona and the current impacts of MDR in an interview with MedTech Insight. 

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June 16, 2022

[FREE WEBINAR] The Role of RA in the Clinical and Performance Evaluation Process: Key Strategies to Support Project Success 

Click here to watch the recording of this webinar.

Regulatory Affairs is poised to play a critical role in supporting the current MDR and IVDR required clinical/performance evaluation process, from project implementation through report writing and finally, the on-time submission to the notified body. From the early planning stage through completion of all required written deliverables, this presentation examines key drivers of project success, such as early assessment of data sufficiency, equivalence considerations, internal readiness of critical documentation, project planning strategies, and how to identify potential roadblocks and proactively find solutions to common problems.   

Key Takeaways

  • Identify critical components of the clinical evaluation process that influence project success. 
  • Describe how Regulatory Affairs can support cross-functional stakeholders and lead critical decision-making throughout the clinical evaluation process. 
  • Recognize and implement early mitigation strategies to overcome roadblocks and drive to on-time submission.

Who Should Watch?

Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions.

Who are the Panelists?

Laurie Mitchell, President | Criterion Edge

Sign up for future webinars here.


Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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