Tag Archives: EU MDR

09Aug/18
EU MDR LSP Tile

Industry Call for EU MDR Freeze

Stop The Clock

MedTech Europe has issued a position paper asking the EU for a “stop the clock mechanism, that freezes the remaining transition time for both regulations until full readiness of the system has been achieved.”  This will create opportunities for Med-Tech companies to take a long view on EU MDR and enable Digital Transformation as a Journey to Support EU MDR and Beyond.

See:  Implementing the New MD and IVD Regulations: Industry Calls for Solutions to Ensure Continuity of Care of Patients. 

EU MDR LSP TileOur Infographic offers you a road map to sustainable, positive disruption.  We’ve also identified some road hazards and areas of interest along the way.

Compliance with Medical Device Regulation 2017/745/EU also commonly referred to as EU MDR, is presenting a significant challenge for the medical device industry.

Executives we’ve talked to have stated:

  • “Older products will present a real challenge for us. 20 and 30 years ago, there weren’t many requirements for human factors, clinical trials and risk data”
  • “We are trying to get our business units to think about the systems as a platform….to execute against business processes which can be shared across organizations”

With the right platform, meeting the next regulatory requirement becomes an issue of formatting the data… not chasing it down.

Briefing requests can be directed to: info@axendia.com

13Jul/18
Lucky 13-700x400

Lucky 13! What’s in a Number?

At Axendia, We Consider 13 More Than a Lucky Number!

We are quickly approaching our 13 Year Anniversary!  Since 2005, we have been providing trusted advice to Life-Science Industry Executives on Business, Regulatory and Technology Matters. It’s more than just luck, our analysts help a diverse set of clients achieve positive disruption through primary research and deep industry experience in a complex and highly regulated Industry.  Not only is our staff passionate about what they do, they average 20 years of Life-Science industry experience.

As a result, Axendia has proudly built long-term relationships across a broad industry ecosystem including:

Life-Science and Healthcare Organizations 68530 Connected Doctor

We provide strategic advice on key initiatives and understand the issues and priorities facing Industry Executives. We architect strategic road-maps to support positive disruption.

Examples include:

Continue reading

22May/18
EU MDR LSP Tile

INFOGRAPHIC: Digital Transformation is a Journey to Support EU MDR and Beyond

Compliance with Medical Device Regulation 2017/745/EU also commonly referred to as EU MDR, is presenting a significant challenge for the medical device industry. Executives we’ve talked to have stated:

  • “Older products will present a real challenge for us. 20 and 30 years ago, there weren’t many requirements for human factors, clinical trials and risk data”
  • “We are trying to get our business units to think about the systems as a platform….to execute against business processes which can be shared across organizations”

Are you lost? Access our Infographic for a road map to sustainable, positive disruption and see for yourself why Digital Transformation is a journey to EU MDR and beyond.  We’ve identified some road hazards and areas of interest along the way.Digital Transformation EU MDR

With the right platform, meeting the next regulatory requirement becomes an issue of formatting the data… not chasing it down.

Register to receive the Infographic today and keep an eye out for additional information.