{"id":6006,"date":"2021-09-22T22:19:50","date_gmt":"2021-09-22T19:19:50","guid":{"rendered":"https:\/\/medfilesgroup.com\/medical-devices-and-ivds\/"},"modified":"2025-05-28T10:38:20","modified_gmt":"2025-05-28T07:38:20","slug":"medical-devices-and-ivds","status":"publish","type":"page","link":"https:\/\/medfilesgroup.com\/ja\/our-services\/medical-devices-and-ivds\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073IVDS"},"content":{"rendered":"\n
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Medical device and IVD services ensure regulatory compliance throughout device lifecycle<\/h1>\n\n\n\n

Medfiles offers comprehensive expert services for medical devices and in vitro<\/em> diagnostic (IVD) medical devices that cover the entire product lifecycle, from establishing a quality management system (QMS) to post-market surveillance (PMS). Utilising our expertise in your product development projects ensures that all regulatory requirements are taken into account from the very beginning. Our team will guide you through the CE marking process and help you prepare the required documentation. If your product is already on the market, you can outsource any post-market duties to us.<\/p>\n\n\n\n

Our experts can help you in various tasks throughout the product lifecycle<\/strong>, whether you want to place your device on the market in the European Union or outside the EU. We are here for you if you want to CE mark your device in compliance with the Medical Device Regulation (EU) 2017\/745 or the In Vitro Diagnostic Regulation (EU) 2017\/746, or register your product in countries outside the EU, which in the USA may require expertise related to the FDA 21 CFR Part 820 and 510(k).<\/p>\n\n\n\n

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Our services cover quality management, technical documentation, clinical evaluations, performance evaluations, product registrations, post-market surveillance (PMS) and vigilance as well as other additional services, such as tailored training in our areas of expertise. If you want to make sure that your product, process or system is compliant with the relevant standards, such as ISO 13485, ISO 14971, ISO 10993, IEC 60601 and IEC 62304, our experts are at your service.<\/p>\n\n\n\n

Because Medfiles has dedicated teams for medicines, clinical studies and laboratory services, our Medical Device and IVD Team has direct access to a wide range of specialist expertise in other fields \u2013 this allows us to provide comprehensive advice, for instance, for substance-based devices and combination devices.<\/p>\n\n\n\n

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Clinical investigation services for medical devices<\/a><\/div>\n<\/div>\n\n\n\n
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Medical device and IVD services<\/h2>\n\n\n\n
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Quality management system according to ISO 13485<\/h2>\n\n\n\n

Most major markets require implementation and maintenance of a quality management system (QMS). With our help, you can meet the specific QMS requirements in different markets around the world. ISO 13485 is an international quality management system standard for medical devices that has been developed to meet the specific needs of the industry. Several markets, however, have their own specific requirements.<\/p>\n\n\n\n

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Let us help you in establishing and implementing the requirements in your market areas into an efficient QMS system by: <\/p>\n\n\n\n