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Introduction to CE certification of medical devices 2022-03-24
All products entering the EU market must have a CE mark that represents a self-conformity declaration to indicate that the pr...
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Introduction to ISO 10993-1:2018 Biocompatibility Standard 2022-03-24
With the release of ISO 10993-1:2018, biocompatibility evaluation has once again become a hot topic of discussion in the indu...
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ISO10993 certification Biocompatibility test content 2022-03-24
ISO10993, or biocompatibility, refers to the compatibility between medical materials and the patient's tissues and physio...
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Medical Device Directive – 93/42/EEC MDD 2022-03-24
Compliance with the Medical Devices Directive is a mandatory requirement for CE representation of medical devices entering th...
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ISO14971 Medical Device Risk Management Requirements 2022-03-24
ISO14971 Medical Device Risk Management Requirements Meets risk management requirements for medical devicesISO14971 Medical...
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ISO14971 Certification Risk Management 2022-03-24
ISO 14971:2007 is the most advanced international standard and is quickly recognized as the best procedure for risk managemen...
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Benefits of ISO14971 Risk Management Certification 2022-03-24
Benefits of ISO 14971 Risk Management Certification The first certification program developed based on the ISO 14971:2007 s...
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FDA 510(K) Application Considerations 2022-03-24
510K Application Notes Some issues to pay attention to when applying to FDA 1. Before applying, it must be clear whether th...
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FDA Product Classification 2022-03-24
FDA implements classified management of medical devices, and divides medical devices into three categories (Ⅰ, Ⅱ, Ⅲ) accordin...
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Domestic Class II Medical Device Registration Approval Procedure 2022-03-24
Domestic Class II medical device registration (re-registration) consists of acceptance, technical review, and administrative ...