21 CFR Chapter I Subchapter H โ Medical Devices โ Part 888 Orthopedic Devices From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 888 Orthopedic Devices". Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Consultation on the International Council for Harmonisation (ICH) M14 From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง Consultation on the ICH E2D(R1) guidelines on General principles on plan, design, and analysis of pharmacoepidemiological studies that utilise real-world data for safety assessment of medicines. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated 3 weeks ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Principle 7: Chemical, physical and biological properties From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Principle 7 has six parts that deal with the design and construction of a medical device Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on August 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Principle 8: Infection and microbial contamination From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Medical devices must be designed and produced in a way that removes or reduces infection risks. They can pose infection risks to patients, users, or others. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Principle 2: Design and construction of medical devices to conform with safety principles From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Manufacturers of medical devices must hold evidence that demonstrates that their devices meet the Principles before their devices can be supplied in Australia. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Principle 11: Protection against radiation From Therapeutic Goods Administration (TGA) ๐ฆ๐บ A medical device must be designed and produced in a way that ensures that the exposure of a patient, the user, or any other person, to radiation is minimised. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Principle 5: Medical devices not to be adversely affected by transport or storage From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Principle 5: A medical device must be designed, produced and packed in a way that ensures that the characteristics and performance of the device. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 10, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Principle 3: Medical devices to be suitable for intended purpose From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Principle 3 requires manufacturers to ensure their devices perform in the way intended. This includes the design, manufacturing process, and packaging. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 10, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 822 Postmarket Surveillance From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 822 Postmarket Surveillance". Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated on June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 820 Quality System Regulation From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 820 Quality System Regulation". Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated on June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
The Target Development Profile Toolkit From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 5, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
EUDAMED โ Colour scheme and layout From European Commission ๐ช๐บ This document outlines the color scheme and layout guidelines for EUDAMED, providing a visual framework for the system's design and user interface. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 20, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
The Innovative Devices Access Pathway (IDAP) From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 29, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval Applications for Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Cream, or Ointment; and Liquid Wound Washes Containing Medically Important Antimicrobials From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2023-26208. The Food and Drug Administration (FDA, Agency, or we) is proposing to require the filing of a premarket approval application (PMA) for certain solid wound dressings; wound dressings formulated as a gel, cream, or ointment; and liquid wound washes containingโฆ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on November 30, 2023 Other (Public Domain) 0 reuses 0 favorites
Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document provides guidance on pivotal clinical investigations for medical devices, covering topics like GCP, IDE, and premarket considerations. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 10, 2023 Other (Public Domain) 0 reuses 0 favorites
TGA laboratories testing report: Survey of microwavable heat packs From Therapeutic Goods Administration (TGA) ๐ฆ๐บ This testing project was designed to assess compliance with the new Standard Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on August 7, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Guidance on Clinical Trials Design of Artificial Intelligence(AI)-based Medical Devices From Ministry of Food and Drug Safety (MFDS) ๐ฐ๐ท This guidance applies to the regulatory pathways of clinical trial approval, manufacturing, and import licensing (subject to clinical trial data submission) or technical documentation review (subject to clinical trial data submission) for machine learning-enabled medical devices that analyzeโฆ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 20, 2023 Other (Public Domain) 0 reuses 0 favorites
Virtual manufacturing of medical devices From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง Guidance for manufacturers who donโt design or manufacture devices but place their names on the product. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 1, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
University student educational materials From Therapeutic Goods Administration (TGA) ๐ฆ๐บ These presentations have been designed specifically for university students who are studying to become health professionals and are in the later stages of their degrees. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 15, 2023 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 874 Ear, Nose, and Throat Devices From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 874 Ear, Nose, and Throat Devices". Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated on January 9, 2023 Other (Public Domain) 0 reuses 0 favorites