Medical device cybersecurity: Here’s how you verify and validate it

Cybersecurity is becoming an essential pillar of medical device design, and it’s important to find the right strategies to validate and verify your products are secure. Michael Lynch and Delmar Howard, Intertek The growth of connected environments has put medical devices at the forefront of the cybersecurity and patient data movement. As more of these

Webinar: How usability research and engineering are changing medical device development

This webinar was recorded on Thursday, August 24, 2017. Click below to watch the webinar on demand. An overview of the history and current state of usability engineering in medical device product development. Highlights include a review of regulatory requirements,  best practice guidance, and case studies showing the application of usability engineering. You will gain

Webinar: Learn the keys to a more predictable time to market

    This webinar will discuss common new product development issues that can have a significant impact on time to market and product quality. The root causes for the most common problems will be identified. Strategic and tactical solutions to address the root causes are highlighted and explained. Webinar Highlights: Managing resources and skill sets

New requirements you should know for medical EMC

Plan now to ensure your medical devices comply with new EMC requirements by the December 2018 effective date. Since the development cycle can be 2-3 years, it is important to understand the new IEC 60601-1-2 EMC 4th Edition standard now when designing medical devices. To provide you guidance on these important changes and improve your

Intertek announces field evaluations services for medical electrical equipment

Intertek, a Total Quality Assurance provider to a range of industries worldwide, announces new field evaluations services to verify medical electrical equipment and systems to CSA Model Code SPE-3000. With these services, Intertek can assist small volume purchasers and importers of medical devices in Canada with the inspection and verification of products to the code’s

Intertek announces services to support eco-friendly medical devices

Intertek, a Total Quality Assurance provider to a range of industries worldwide, is announcing new services to help manufacturers of medical electrical equipment verify their products are environmentally conscious. The services are an expansion of Intertek’s existing IEC 60601-1 services and consist of an engineering review of product design and development processes in line with

Intertek Announces New Service for Mobile Health Applications

Intertek is announcing a new service for mobile health applications, the 6-Point Security Check, which assesses the cybersecurity of browser-based applications, mobile or embedded applications with a cloud backend and Cloud architecture. The security check is designed to identify deficiencies and vulnerabilities and to develop recommendations for correcting issues discovered during the assessment. Data security

A guide to meeting the IEC60601-1-11 standard in home healthcare devices

Population growth, an increasing rate of chronic disease and economic factors are behind the growing demand for medical electrical equipment for use in home settings. Concurrently, the level of knowledge or understanding by the patient or caregiver, environmental factors and unpredictable factors are placing greater demands on the safety, durability and operability of medical equipment