Pages that link to "Glossary:TAG-00155-Med-Med"
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The following pages link to Glossary:TAG-00155-Med-Med:
Displaying 50 items.
- Glossary (← links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.8 (← links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I 6.3 (← links)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 45 (← links)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 47-001 (← links)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 (← links)
- Reference:GBR Directive 93/42/EEC 11-Oct-2007 ANNEX X 2.1 (← links)
- Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 18 (← links)
- Reference:USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 - (← links)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.1 (← links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-001 (← links)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 1 - 3 (← links)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 2 – 3 (← links)
- Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 2 in vitro diagnostic medical device (← links)
- Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 2 medical device (← links)
- Reference:USA U.S. Code Title 21 30-Sep-2023 § 321 (h) (← links)
- Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 510 (k) (← links)
- Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 512 (f) (← links)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 51 (← links)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex VIII (← links)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 6 (← links)
- Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 9 (← links)
- Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Section 513 (← links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I (← links)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 1 (← links)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 74 (← links)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 Absatz 4 (← links)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble Preamble (← links)
- Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (9) (← links)
- Reference:USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018 - (← links)
- Reference:USA Recognized Consensus Standards - ISO 14155 21-Dec-2020 - (← links)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 85 (← links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.24 (← links)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (f) (← links)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (t) (← links)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 70 Paragraph 1 (← links)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 73 (← links)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 31 (← links)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 33 (← links)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 47-002 (← links)
- Reference:FRA SI RIPH 2G - Website 16-May-2025 - (← links)
- Reference:FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025 - (← links)
- Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 16 (1) - (3) (← links)
- Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 2. (← links)
- Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart B (← links)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.30 (← links)
- Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart D (← links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-001 (← links)
- Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart G (← links)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.25 (← links)