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 […]
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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.
