Robert Dostert, DNV

The EU Medical Device Regulation (MDR): What Lessons Have We Learned?

By Robert Dostert

…technical data should begin (but not end) by completing an Annex I – General Safety and Performance Requirements (GSPR) checklist. Completing the GSPR checklist will allow the manufacturer to see…

…technical data should begin (but not end) by completing an Annex I – General Safety and Performance Requirements (GSPR) checklist. Completing the GSPR checklist will allow the manufacturer to see…

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magnifying glass

Legal and Normative Requirements: Ensuring the Functional Safety of Medical Devices

…not immediately result in a single fault. Upon occurrence of a single fault, a latent fault causes the protective system to fail. Recognizing this shortcoming, the International Electrotechnical Commission (IEC)…

…not immediately result in a single fault. Upon occurrence of a single fault, a latent fault causes the protective system to fail. Recognizing this shortcoming, the International Electrotechnical Commission (IEC)…

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Robert Dostert, DNV

Ask the Expert: The EU Medical Device Regulation (MDR) – Is Anyone Ready and Where Are We Headed?

By Robert Dostert

…and limited resources. What does this really mean? Well, in short, there are not enough resources to handle all of the new applications coming. We recommend speaking with your consultant

…and limited resources. What does this really mean? Well, in short, there are not enough resources to handle all of the new applications coming. We recommend speaking with your consultant

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Operational Excellence: Charting a path to operational excellence with a focus on manufacturing

Operational Excellence: Charting a path to operational excellence with a focus on manufacturing

By Siemens

Download this white paper today and find out how operational excellence for medical devices helps enterprises go beyond the complex modern requirements of medical device manufacturing. Learn how eliminating manual…

Download this white paper today and find out how operational excellence for medical devices helps enterprises go beyond the complex modern requirements of medical device manufacturing. Learn how eliminating manual…

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James Thompson, Siemens

Ask the Expert: Leveraging the Digital Infrastructure to Align with Best Practices and Accelerate Growth

By MedTech Intelligence Staff

…economies and the new FDA and EU Regulatory implications have led to a point that even the most seasoned professional has difficulty navigating them. Today, Medical Manufacturers competing in this…

…economies and the new FDA and EU Regulatory implications have led to a point that even the most seasoned professional has difficulty navigating them. Today, Medical Manufacturers competing in this…

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Peter Willemse, Experlogix

Ask the Expert: How Can Medical Device Manufacturers Benefit from Configure, Price, Quote (CPQ) Software

By Experlogix, LLC

…timeframe. Changes in the operation while fulfilling orders because of faulty quotes are a common thing customers struggle with. Also, the time to process quotes after the customer commits is…

…timeframe. Changes in the operation while fulfilling orders because of faulty quotes are a common thing customers struggle with. Also, the time to process quotes after the customer commits is…

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Reduce Your Medical Device Time-to-Market with CPQ Software

Reduce Your Medical Device Time-to-Market with CPQ Software

By Experlogix, LLC

…quote) software can help your company save money, increase customer satisfaction, and generate real ROI. Download our latest datasheet to learn more about how CPQ software can help your business….

…quote) software can help your company save money, increase customer satisfaction, and generate real ROI. Download our latest datasheet to learn more about how CPQ software can help your business….

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Geoff Wood, DNV

Ask the Expert: What Advantages Does a Pre-Assessment Offer?

…stage 1 and stage 2 audit and lead to significant delay in obtaining ISO 13485:2016 or other certification. However, any manufacturer, who plans to add a Medical Device (MD) certification…

…stage 1 and stage 2 audit and lead to significant delay in obtaining ISO 13485:2016 or other certification. However, any manufacturer, who plans to add a Medical Device (MD) certification…

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Evidence Partners

How Literature Review Automation Improves CER and PER Program Management

By Marc Dufresne

…across the company. But the biggest benefit is time: Research teams spend less time completing logistical tasks such as data entry and more time using their expertise to complete a…

…across the company. But the biggest benefit is time: Research teams spend less time completing logistical tasks such as data entry and more time using their expertise to complete a…

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