ISO 13485:2016 pdf download – Medical devices — Quality management systems — Requirements for regulatory purposes

02-16-2022 comment

ISO 13485:2016 pdf download – Medical devices — Quality management systems — Requirements for regulatory purposes.
3.10 manufacturer natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person[s) Note 1 to entry: This “natural or legal person” has ultimate legal responsibility for ensuring compliance with all applicable regulatory requirements for the medical devices in the countries or jurisdictions where it is intended to be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory Authority (RA) within that jurisdiction. Note 2 to entry: The manufacturer’s responsibilities are described in other GHTF guidance documents. These responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse event reporting and notification of corrective actions. Note 3 to entry: “Design and/or manufacture”, as referred to in the above definition, may include specification development, production, fabrication, assembly, processing, packaging, repackaging, labelling, relabeling, sterilization, installation, or remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for a medical purpose. Note 4 to entry: Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation does not change the intended use of the medical device. Note 5 to entry: Any person who changes the intended use of, or modifies, a medical device without acting on behalf of the original manufacturer and who makes it available for use under his own name, should be considered the manufacturer of the modified medical device.
5.5.2 Management representative Top management shall appoint a member of management who, irrespective of other responsibilities, has responsibility and authority that includes: a) ensuring that processes needed for the quality management system are documented; b) reporting to top management on the effectiveness of the quality management system and any need for improvement; ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.

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