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As manufacturers of medical devices we are required to comply with a wide range of country specific regulations and are routinely audited for compliance to the applicable regulations. Our products destined for the United States must comply with the US Food and Drug Administration Quality System Regulation and require market clearance prior to

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A seamless continuing education experience makes excellence easier for everyone. Not only can you complete courses anywhere, any time, on any device, you can stay ahead of the game with recertification reminders, track all your credits and certifications, easily earn contact hours, and, as an admin, upload your own training.

Guidelines for Classification of Medical Devices CE

Guidelines for Classification of Medical Devices CE Marking (CE Mark) for Medical Devices EU Council Directive 93/42/EEC. Register/Notify your MDD Medical Devices and Australia, New Zealand and Israel: What is CE marking (CE mark)?

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Basics of the Medical Device Classification System

This blog will be a guide to the basics of the medical device classification system under the Medical Device Directive Annex IX and what restrictions exist at each class level. Class I Devices Non evasive, everyday devices or equipment. Class I devices are generally low risk and can include bandages, compression hosiery, or walking aids.

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Bringing innovative medical device technology to the marketplace is a highrisk venture. Thats why Element strives to provide absolute testing certainty by delivering accurate and reliable results for our clients medical device testing needs, from small, start up ventures to large, established manufacturers.

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As manufacturers of medical devices we are required to comply with a wide range of country specific regulations and are routinely audited for compliance to the applicable regulations. Our products destined for the United States must comply with the US Food and Drug Administration Quality System Regulation and require market clearance prior to

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APEX Medical Corporation was founded in 1990, it has become a patient focused, innovation driven global medical solution provider during the development over two decades. APEX is committed to delivering medical solutions suited for the specific needs

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Medical facilities and professionals arent set up to understand all the complexities of the industry, professionals are taught to practice medicine not deal with management in an increasingly complicated industry. We are the industry leader for solving complicated business problems, providing state of the art products and support.

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The focal point of our Quality Management System is the high quality requirement regarding the performance and safety of our products and the satisfaction of our customers Medical devices produced by VBM fulfill the requirements of the Medical Device Directive (MDD) 93/42/EEC for Medical Devices and are identified with the CE Marking accordingly.

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Need more Steel information? Contact Us. We're here to help.

Please fill in the following form or email us to get more details [email protected] , we will reply to you within 24 hours.