November 17, 2021

[Ask the Expert] Safety and Performance

This session’s topic: Safety and Performance Measures and Acceptance Criteria

Do you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What are the best strategies for the verification of device safety and performance? Are you demonstrating that your safety and performance objectives are appropriate and clinically relevant​? Do you know how to specify acceptance criteria that are used to determine the acceptability of benefit-risk?

During this presentation, President Laurie Mitchell and Principal Medical Writer, Dr. Sarah Chavez, answer questions on how to identify meaningful safety and performance endpoints, ensure they are appropriate and clinically relevant, how to specify acceptance criteria ranges, and more.

Who should watch the recording?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Clinical Evaluation or Performance Evaluation Reports for EU MDR or IVDR submissions

Click here to watch the recording!

Clearly Defining Measurable Safety and Performance Endpoints

The newest regulations for medical devices, Medical Device Regulation (MDR) 2017/745 and MEDDEV 2.7/1 revision 4, set high standards for confirming safety and performance according to the manufacturer’s Instructions for Use. Previously, regulations under the old MDR and MEDDEV were not as demanding. Also, manufacturers are not accustomed to the current systematic process of CER evaluations.  

These relatively new requirements for clinical evaluation extend to manufacturers sending new products into the European market. Additionally, those that are already selling medical devices will have to follow these new requirements. Safety and performance are central components of the evidence-based evaluation process for obtaining and maintaining CE Marking for MDR 2017/745 and MEDDEV 2.7/1 rev 4. Consequently, medical device manufacturers felt the pressure to comply by May 2021.

Read more on this topic in our blog post, here.

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September 22, 2021

[Ask the Expert] Safety and Performance

safety and performance measures

This session’s topic: Safety and Performance Measures and Acceptance Criteria

Do you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What are the best strategies for the verification of device safety and performance?

During this 45-minute Q&A session, our President Laurie Mitchell answers questions on how to identify meaningful safety and performance endpoints. In addition she discusses how to demonstrate that S&P endpoints are appropriate and clinically relevant​, as well as how to specify acceptance criteria to determine the acceptability of benefit-risk.

Who should watch this webinar?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Clinical Evaluation Reports for EU MDR or IVDR submissions

Watch the recording!

Clearly Defining Measurable Safety and Performance Endpoints

The newest regulations for medical devices, Medical Device Regulation (MDR) 2017/745 and MEDDEV 2.7/1 revision 4, set high standards for confirming safety and performance according to the manufacturer’s Instructions for Use. Previously, regulations under the old MDR and MEDDEV were not as demanding. Also, manufacturers are not accustomed to the current systematic process of CER evaluations.  

These relatively new requirements for clinical evaluation extend to manufacturers sending new products into the European market. Additionally, those that are already selling medical devices will have to follow these new requirements. Safety and performance are central components of the evidence-based evaluation process for obtaining and maintaining CE Marking for MDR 2017/745 and MEDDEV 2.7/1 rev 4. Consequently, medical device manufacturers felt the pressure to comply by May 2021.

Read more on this topic in our blog post, here.

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September 1, 2021

[Ask the Expert] Systematic Literature Review

systematic literature review

This session’s topic: Systematic Literature Review: What is it and why is it so important?

Do you have specific questions about the steps of the systematic literature review process or questions regarding your medical device or IVD? During this 45-minute Q&A session, our President Laurie Mitchell answers questions about the steps to conduct a methodologically sound SLR​​. In addition, she discusses how to leverage published data to meet regulatory expectations and inform internal decision-making from marketing initiatives and clinical strategies to global regulatory requirements.

Who should watch this webinar?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Systematic Literature Reviews for EU MDR or IVDR submissions, meta-analyses, regulatory response support, development of clinical marketing materials, etc.

Watch the recording!

Watch Our Related Webinar for an In-Depth Look at the SLR Process

With the implementation of IVDR and MDR requirements, device manufacturers often struggle to align their internal processes and systems to comply with these rigorous regulations. Consequently, companies realize the need to review published literature for device-specific clinical data. However many manufacturers may not be familiar with or have the capability to perform all steps of the rigorous systematic literature review process, including screening, selection and data extraction. 

Watch our webinar where we break down the steps of the SLR process and take a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR). We encourage professionals from the medical device industry to watch as well, as the content is also relevant to MDR requirements, which align closely with IVDR.

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June 15, 2021

[FEATURED] Sprinting To Approval: Insider Tips On FDA’s Breakthrough Devices Program

Manufacturers applying to the program should be ready for questions from the US agency, an FDA official says.

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August 7, 2019

[FEATURED] Two More Notified Bodies About To Be Designated And Surge In Publications Of New Documents

The European Commission came under a great deal of pressure in June to deliver the fundamental structures and documents needed for implementing the EU’s new medtech regulations. It has hit the ground running so far this month.

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