Tag Archives: Regulatory Compliance

22May/18
EU MDR LSP Tile

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

Achieve Sustainable, Positive Disruption

By: Sandra K. Rodriguez, Market Analyst

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.

04Apr/18
Quality+IoMT-800x600

Quality: STOP Working on Compliance

Excessive focus on compliance can create hurdles in cultivating quality and innovation

By: Daniel R. Matlis, President

What is the role of Quality in MedTech? 10% said the primary role of quality is to drive product / process improvement. In sharp contrast, 85% indicated the primary role of quality is ensuring compliance

No wonder, the industry has to overcome some many hurdles when cultivating a culture of quality and innovation.

To compete in today’s global markets, Med-Tech companies must change their approach to Quality, from meeting compliance requirements, to driving product and process improvements across the product life-cycle.

A closed loop approach can help MedTech organizations make this crucial shift by enabling better collaboration, visibility and product quality across the product life-cycle.

Axendia_CultureQuality

Read my latest Soapbox column in MedTech Intelligence for key takeaways from Axendia’s research on this topic.