Effective post-market surveillance - BSI Group

PMS NBMed 2.12 Vigilance MEDDEV 2.12-1 Post-market clinical follow-up MEDDEV 2.12-1 Reactive PMS Proactive PMS Proactive Reactive • Customer surveys • Post CE mark clinical trials, including PMCF • Manufacturer sponsored device tracking/implant registries • Expert user groups (focus groups) • Customer complaints

  Meddev, Meddev 2

Medical Device White Paper Series Medical device clinical ...

MEDDEV 2.7/2 Rev 2 on clinical investigation validation and assessment by competent authorities MEDDEV 2.7/3 Rev. 3 on serious adverse event (SAE) reporting New requirements under the MDR The MDR introduces new requirements, which need …

  Meddev, Meddev 2

EUROPEAN COMMISSION DG Health and Consumers ... - …

MEDDEV 2 12-1 rev. 8 Vigilance 6 d) devices that do not carry the CE-mark but where such INCIDENTs lead to CORRECTIVE ACTION(s) relevant to the devices mentioned in a), b) and c). These guidelines cover FIELD SAFETY CORRECTIVE ACTION relevant to CE-marked devices which are offered for sale or are in use within the EEA, Switzerland and Turkey. ...

  Meddev, Meddev 2

EN 62304 - Frequently Asked Questions - Team NB

See MEDDEV 2.1/6 (chapter 2). 2.1.3 How does the standard distinguish between open and closed systems? Answer: There is no differentiation in the standard between closed or open systems. 2.1.4 Assuming all software has a medical purpose, does the standard apply to the

  Question, Frequently, Asked, Frequently asked questions, Meddev, Meddev 2

MedDev 2.7.1 Rev 4 Medical Devices Regulation Clinical ...

MedDev 2.7.1 –6.2.3 Updating the clinical evaluation • on receipt of new information from PMS that has the potential to change the current evaluation • at least annually if the device carries significant risks or is not yet well established • every 2 to 5 years if the device is not expected to carry significant risks and is well established

  Meddev, Meddev 2

A guide to the In Vitro Diagnostic Directive - BSI Group

A BSI guide to the In Vitro Diagnostic Directive Introduction In Vitro Diagnostics (IVD) is an essential and fast growing part of the global healthcare system, as they add value to patients, medical professionals and the industry along with enhancing the well-being

  Directive, Diagnostics, Vitro, The in vitro diagnostic directive

Tecnovigilancia - Secretaría de Salud de la Ciudad de México

2 “Informe de Tecnovigilancia por producto, en términos de .1 de Tecnovigilancia?-220 “Instalación y operación de la Farmacovigilancia”, la cual ormación sobre los efectos de los medicamentos, productos 3 xisten Unidades y Centros de Médicos , las cosas no son tan claras. Marzo 2010. Año 2, Número 1 se deben cumplir