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The Health Industry

SpecialChem / Jan 26, 2007

Medical devices are one of the most highly regulated groups of products manufactured in the world. Regulatory requirements are in place to assure the efficacy, safety and integrity of about-to-be-marketed devices. These same regulations however can also cause considerable headaches for companies struggling with the intricacies of meeting a myriad of requirements while trying to introduce a new device to multiple markets in a global economy. Whether a medical device manufacturer is just beginning the regulatory process, preparing submission for FDA 510(k), Canada Health CMDCAS, Japan PAL, China SFDA, EU directives or other government regulatory submissions, developing a technical file and design dossier for CE marking, or planning for a regulatory audit, there are international consulting companies with the intimate knowledge of medical device regulations and technical expertise to assist and guide companies through the various requirements to bring their medical products to market efficiently and cost effectively.

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