Category Archives: Regulatory

13Mar/17
CyberSecurity

CYBERSECURITY RISKS IN MEDICAL DEVICES ARE REAL

By: Eric M. Luyer, Market Research Analyst 

The Healthcare Industry Has a New Set of Threats on Its Hands

PPP_IGLOB_CLP_Global_Computer_Network_Red_Color_Pencil_HEXConnected medical devices-like other computer systems-can be vulnerable to security breaches and have a potential major impact on safety and effectiveness of the device.  Specifically, in a healthcare environment, this vulnerability increases asmedical devices and medical equipment are becoming more connected through the internet to other medical devices, patients and/or to hospital networks (also referred to as the Internet of Medical Things).

To address the cybersecurity threat, in December 2016 FDA issued Guidance on Postmarket Management of Cybersecurity in Medical Devices.

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08Mar/17
Supply-Chain-Squares (3)

QUALITY MANAGEMENT ACROSS YOUR GLOBAL SUPPLY CHAIN

How Can the Cloud Help with Data Integrity and Quality Issues Across your Global Supply Chain?

REGISTER TODAY
Date: MARCH 22, 2017
Time: 1:30 PM EST

All your data used to be close by — under your control — and easily monitored. Now, as you outsource more and more, your direct control on quality is weakened. By using a cloud based solution you can take back control. You can monitor your quality metrics in real time wherever they’re being generated and head off issues way before an FDA investigator even sets foot in your facility.

In this session, you will learn how to:

  • Drive enhanced product quality at reduced costs and risks while assuring compliance with all applicable regulatory requirements
  • Leverage modern quality systems to improve visibility, control and collaboration across your supply chain
  • Shift from just documents to also including data to support quality metrics across global and externalized supply chain networks
  • Reduce inspection frequency and risk through modern quality systems and real-time quality metrics
  • Reduce data integrity risks before they occur
  • Sleep better at night!

Attend the Webinar – Sponsored by Veeva

01Feb/17
FDA_small

Hear Directly from FDA: Driving a Culture of Quality for Devicemakers

Webinar Announcement

FDA and Industry Find Common Ground Driving a Culture of Quality

DATE: March 1, 2017
TIME: 1:30PM Eastern

Industry leaders and regulators are working on the Case for Quality (CfQ) initiative to shift their focus from compliance to quality by giving greater focus and emphasis to critical-to-quality practices throughout the lifecycle of the product.

Would you like to reduce your regulatory burden? Pay dividends in enhanced and predictable product performance? Streamline processes resulting in operational efficiencies? Reduce waste driving to lower costs and improved profitability?

CFQ_Webinar1

Join Sean Boyd — Deputy Director for Regulatory Affairs, CDRH’s Office of Compliance — Francisco (Cisco) Vicenty — Program Manager (Acting), Case for Quality, FDA — and Daniel R. Matlis — President, Axendia — on March 1st when they’ll discuss the effect the CfQ will have on med-tech manufacturers, healthcare providers, regulators and ultimately the patient.

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