By Derek Silva, Vice President, Marketing, Intertek As the medical device landscape evolves with increasing connectivity and technological advancements, cybersecurity has become a critical priority. Regulatory bodies worldwide are implementing stringent guidelines that require manufacturers to integrate robust cybersecurity measures into their products. This guide outlines the latest advancements in medical device cybersecurity, providing engineers, […]
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Defining Modern Day “Quality Assurance” for Medical Devices
By Derek Silva, Vice President, Marketing, Intertek There once was a day when a product might have been deemed “quality checked” if a tiny paper slip fell out of its packaging, saying “Tested by Number 9”. The scrutiny back then, you could argue, was a bit less meticulous than desired. Fast forward to nearly a […]
The Evolution of Home Healthcare
by Clarissa Benfield, Global Director of Medical & Laboratory Equipment, Intertek Medical devices have been used in the home for many years to monitor vital statistics such as weight, blood pressure, fluid intake, oxygen saturation rate, etc. For many reasons, the market for these and other home-use medical devices has grown significantly, especially within the […]
Testing and certification of refurbished medical equipment
By L. Matthew Snyder, Sr. Director of Certification at Intertek Medical electrical equipment such as MRIs, anesthesia machines, surgical equipment, scanning systems, patient monitors and other types of products are a significant investment for any healthcare organization. Refurbished medical equipment, devices that are reconditioned and made comparable to new products, are becoming a realistic option […]
New Requirements for Medical EMC: IEC 60601-1-2 Edition 4
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 […]
5 Steps to Medical Device Commercialization in the U.S.
Speed your medical devices to market with this complimentary guide which takes you step by step through the process of submitting your medical devices for approval from the FDA. As a leader in third party testing and certification, Intertek’s industry experts developed this guide to simplify the complex process to submit your medical devices to […]
Intertek Guides Manufacturers through the New Safety Requirements for Home Healthcare
Boxborough, MA, USA: Intertek (LSE: ITRK), a leading provider of quality testing, inspection and certification services, continues to educate manufacturers of medical electrical equipment intended for use in the home healthcare environment about the new requirements of IEC 60601-1-11. Intertek recently released a technical paper identifying the safety and regulatory requirements of the collateral standard necessary to sell home healthcare equipment into global markets.
