IQVIA Quality Compliance

EU MDR readiness isn’t just a single activity – and is not isolated to a company’s activities in the EU. It requires changes to processes across your organization.

As you prep for the looming EU MDR 2020 compliance deadlines, are you ready? These previously published blogs provide insight into the components of the medical device product lifecycle, from concept to market, that you need to consider in assessing your organization’s preparedness for the May 2020 deadline.

• EU MDR: The Clock is Ticking…Are You Equipped?
  Are you prepared for the implementation of EU MDR, or do the impending regulations have you more worried than you’d like to admit? Read about the anticipated impact of EU MDR on the medical device industry, and recommended solutions and technologies that can help your organization prepare to comply.
• The Medical Device Regulatory Landscape is Impacting Supplier Control
  Today’s global economy has added complexity to supply chains, and longer supply chains are making it increasingly difficult to manage our suppliers, and in many cases our suppliers’ suppliers, thereby increasing overall risk.
• Proactive Post-Market Surveillance: Medical Devices and IVDs
  Regulatory authorities are requiring a more proactive Post-Market Surveillance approach among Medical Device and IVD manufacturers. Adopting a proactive approach and a centralized safety function will reduce the costs of downstream corrective actions and the risk of patient harm.
• Strategic Planning for the EU Medical Devices Regulation: Have You Spoken to Your Notified Body Yet?
  Manufacturers and distributors selling into the EU should already be transitioning to meet the new Medical Devices Regulation (2017/745/EU). This is the time for assessing Notified Bodies to the MDR.
• EU Medical Device Regulations: Changes on the Horizon
  Don’t wait! Significant changes are coming to the Medical Device industry within the next few years, impacting many quality, compliance, and risk-related processes. Take a high-level look at some of the requirements being put into place.