Tag: Postmarketing surveillance

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New Medical Device Regulations Take Effect in Europe

Added to Collection on: 2021-06-02 20:00:36

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Medical device
Regulation (EU) 2017/745
Regulation (EU) 2017/746
Postmarketing surveillance
Risk management
Regulatory affairs
Notified body
Single Use Medical Device Reprocessing
Alan Fraser

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European Union: How Will Europe's New Device Regulations Affect Medical Software?

Added to Collection on: 2021-06-11 07:07:30

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Food and Drug Administration
Health
Regulation
Regulation (EU) 2017/745
Medical device
Unique Device Identification
Pharmaceuticals policy
Regulation (EU) 2017/746
Postmarketing surveillance
Notified body
Medical Devices Directive
Wolfgang Schönig
MORRISON & FOERSTER LLP

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Celegence Releases Cutting Edge EU MDR Compliance Technology, CAPTIS

Added to Collection on: 2021-08-11 04:52:30

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Medical device
Medical writing
Regulation (EU) 2017/745
Postmarketing surveillance
Regulation (EU) 2017/746
Documentation
Regulatory affairs
Business process management
MDR
Celegence

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Introduction to the In-Vitro Diagnostic Regulation (IVDR) Online Training Course (November ...

Added to Collection on: 2022-05-16 16:11:08

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Medicine
Technology
Regulation (EU) 2017/746
Medical technology
Medical equipment
Regulation (EU) 2017/745
Medical device
ISO 13485
Regulatory affairs
Postmarketing surveillance
IVD
ResearchAndMarkets.com

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European Union: In Vitro Diagnostic Regulation Entered Into Force (Part 1 Of 3) - Mondaq

Added to Collection on: 2022-06-01 14:26:17

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Medicine
Health
Regulation (EU) 2017/746
Regulation (EU) 2017/745
Clinical research
Clinical trials
Pharmaceuticals policy
Medical device
Postmarketing surveillance
Companion diagnostic
Notified body

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Ireland Adopts New IVDR Enforcement Measures - Life Sciences, Biotechnology & Nanotechnology

Added to Collection on: 2022-07-04 16:42:22

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Regulation (EU) 2017/745
Regulation (EU) 2017/746
Clinical research
Clinical trials
Pharmaceuticals policy
Health
Postmarketing surveillance
Medical device
Articles
IVDR
Regulatory compliance

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Celegence adds new feature for efficient compliance documentation - Med-Tech Innovation

Added to Collection on: 2022-07-08 13:34:47

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Health
Technology
Regulation (EU) 2017/746
Regulation (EU) 2017/745
Clinical research
Clinical trials
Pharmaceuticals policy
Medical device
Medical devices
Notified body
Postmarketing surveillance
CAPTIS
Shutterstock

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Innovation-Based discernment to drive the Unique Device Identification Market - WhaTech

Added to Collection on: 2022-11-12 09:21:07

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Health
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Cryptography
Food and Drug Administration
Healthcare in the United States
Identifiers
Unique Device Identification
Medical device
Identification
Postmarketing surveillance
UDI
Big data

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CS MEDICA A/S: The proposal to extend the transition period under the Medical Devices ...

Added to Collection on: 2022-12-19 14:11:03

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Health
European Union directives
Medical device
Notified body
MDR
Medical Devices Directive
Postmarketing surveillance
Medicine

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European Commission Proposes Extension for EU IVDR Compliance

Added to Collection on: 2024-01-24 18:21:41

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Regulation of medical devices
Regulation (EU) 2017/745
Regulation (EU) 2017/746
Medical device
Medicines and Healthcare products Regulatory Agency
Postmarketing surveillance

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