Showing 65–80 of 121 results
ISO 13485:2016 QMS Template – Master Document List Enhance your Quality Management System with our ISO 13485:2016 compliant Master Document List template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause and…
ISO 9001:2015 QMS Template – Master Document List (QMS.7.5.3.1 – QR) Enhance your Quality Management System with our ISO 9001:2015 compliant Master Document List template. Created by the fully qualified and experienced professionals at Patient Guard, this template meets the specific requirements of each clause and section of the ISO 9001:2015 standard. Why Choose Our…
ISO 13485:2016 QMS Template – Master Software List (QMS.4.1.6.1 – LQR) Enhance your Quality Management System with our ISO 13485:2016 compliant Master Software List template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of…
ISO 13485:2016 QMS Template – Measurement and Analysis Procedure (QMS.8.4.0 – QP) Enhance your Quality Management System with our ISO 13485:2016 compliant Measurement and Analysis Procedure template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific…
ISO 9001:2015 QMS Template – Measurement Traceability Enhance your Quality Management System with our ISO 9001:2015 compliant Measurement Traceability Procedure template. Created by the fully qualified and experienced professionals at Patient Guard, this template meets the specific requirements of each clause and section of the ISO 9001:2015 standard. Why Choose Our Measurement Traceability Procedure Template?…
Medical Device File (Technical File) Folder Structure Our Medical Device Quality Assurance and Regulatory Affairs document templates have been created by fully qualified and experienced professionals at Patient Guard, a Quality Assurance and Regulatory Affairs Service provider. The templates have been specially written to ensure that they meet the basic requirements needed for each clause…
ISO 13485 – QMS.4.2.3.1 – Medical Device File Template – UKCA Marking This medical device template covers the requirements of the UK Medical Device Regulations 2002 for the purposes of UKCA Marking of medical devices. As of June 2023 all medical devices sold into the UK are required to have a UKCA mark technical file….
In accordance with Article 11 of European Medical Device Regulation 2017 745 manufacturers who are based in 3rd countries (countries not based within an EU member country) are required to have an Authorised Representative. The Regulation states that there must be a mandate in place between the Manufacturer and the Authorized Representative. The Regulation provides…
Device Risk Identification, Analysis and Control Template – EN ISO 14971:2019+A11:2021 As part of the requirements for placing a medical device or IVD on the market, the manufacturer needs to demonstrate that risk management of the device has taken place. There is a risk management standard for medical devices named EN ISO 14971. This standard…
Device Risk Management Plan Template – BS EN ISO 14971:2019+A11:2021 As part of the medical device risk management activities, a medical device must demonstrate compliance with risk management standard EN ISO 14971. The standard states that there must be a risk management plan in place, which details the actions required to perform risk management activities…
ISO 13485:2016 QMS Template – Non-Conformance Report Log (QMS.8.3.2.1 – QR) Enhance your Quality Management System with our ISO 13485:2016 compliant Non-Conformance Report Log template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of…
ISO 9001:2015 QMS Template – Non-Conformance Log (QMS.10.2.2 – QR) Enhance your Quality Management System with our ISO 9001:2015 compliant Non-Conformance Log template. Created by the fully qualified and experienced professionals at Patient Guard, this template meets the specific requirements of each clause and section of the ISO 9001:2015 standard. Why Choose Our Non-Conformance Log…
ISO 13485:2016 QMS Template – Non-Conformance Procedure (QMS.8.3.2 – QP) Enhance your Quality Management System with our ISO 13485:2016 compliant Non-Conformance Procedure template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause…
ISO 9001:2015 QMS Template – Non-Conformance Procedure (QMS.10.2 – QP) Enhance your Quality Management System with our ISO 9001:2015 compliant Non-Conformance Procedure template. Created by the fully qualified and experienced professionals at Patient Guard, this template meets the specific requirements of each clause and section of the ISO 9001:2015 standard. Why Choose Our Non-Conformance Procedure…
ISO 13485:2016 QMS Template – Non-Conformance Report (QMS.8.3.2.2 – QR) Enhance your Quality Management System with our ISO 13485:2016 compliant Non-Conformance Report template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause…
ISO 9001:2015 QMS Template – Non-Conformance Report (QMS.10.2.1 – QR) Enhance your Quality Management System with our ISO 9001:2015 compliant Non-Conformance Report template. Created by the fully qualified and experienced professionals at Patient Guard, this template meets the specific requirements of each clause and section of the ISO 9001:2015 standard. Why Choose Our Non-Conformance Report…
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