Example: air traffic controller
Post-market surveillance - Medical Device Regulation
Describes means of tracing and identifying devices References the documented procedures for the – Summarizes the results and conclusions of analysis of the PMS data Includes rationale for, and description of, any preventive action or corrective actions taken Updated when necessary and made available to the competent authority upon request
Tags:
Information
Domain:
Source:
Link to this page:
Documents from same domain
Medical Device White Paper Series Risk management for ...
www.medical-device-regulation.euthe need to develop an international standard for risk management of medical devices and established their Joint Working Group 1. EN 1441 [15] was taken as a starting point and was converted with minimal editing to BS EN ISO 14971-1 [16] in 1998, which thus also covered risk analysis. BS EN ISO 14971-1 was intended to be
Technical Documentation and Medical Device Regulation
www.medical-device-regulation.euthe device to the NB for pre-market or post-market conformity assessment activities. With the aim of globally standardizing medical device regulatory submissions, the Global Harmonization Task Force (GHTF) has created the ‘Summary Technical Documentation (STED)’, intended to be a consistent, summarized or abridged form of the
MDR Labelling Requirements - Medical Device Regulation
www.medical-device-regulation.eu•Sterile package requirements (23.3) • AIMDD already distinguishes sterile pack from trade pack / sales pack; this distinction is new to MDD devices • Mostly a sub-set of existing labelling requirements •“an indication permitting the sterile packaging to be recognized as such,”–i.e. disclaimers, sterile symbol,
Medical Device White Paper Series Sterilization ...
www.medical-device-regulation.euNew emphasis on cleaning, disinfection and sterilization of reusable devices. Table 1 – Comparison of the requirements in relation to Infection and microbial contamination in the Medical Devices Regulation and the Medical Devices Directive 1 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices,
Comparison of the articles of the European Medical Devices ...
www.medical-device-regulation.eupages. This table presents a summary of the provisions of some of the articles of the MDD and MDR together with commentary providing discussion and highlighting the key differences. The table is an excerpt from the MDR/IVDR Smart Support available in Compliance Navigator. Topic Scope - inclusions Medical Devices Directive (93/42/EEC), as amended
REGULATION (EU) 2017/ 745 OF THE EUROPEAN …
www.medical-device-regulation.eu5.5.2017 EN Official Jour nal of the European Union L 117/3 (1) Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121). (2 (((
Medical Device White Paper Series Medical device clinical ...
www.medical-device-regulation.euMEDDEV 2.7/3 Rev. 3 on serious adverse event (SAE) reporting New requirements under the MDR The MDR introduces new requirements, which need to be carefully reviewed and addressed in applicable procedures for the conduct of clinical investigations under the MDR. The new MDR requirements presented
MedDev 2.7.1 Rev 4 Medical Devices Regulation Clinical ...
www.medical-device-regulation.euClinical Evidence –MedDev 2.7.1 & MDR Clinical Evidence Clinical Evaluation Clinical Data •the clinical data and clinical evaluation report pertaining to a device •sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s) when used as intended by the manufacturer
Related documents
AUDIT REPORT – MANUFACTURING DEPARTMENT
www.oz1consulting.comBased on our observations, audit and analysis, we conclude that the manufacturing and materials ... performance of the department and infrastructure. ... diagram is a visual representation using a continuous flow line tracing the path of an item or activity through a process. The continuous flow line enables process teams to identify ...
DEPARTMENT OF THE AIR FORCE - AF
software.af.mil1.4. Construct models to enable the following to be traced from the requirements: analysis of requirements, system architecture design, allocations, interfaces, certifications, and functional thread analysis. 1.5. Include capabilities to predict operational performance and quantify uncertainty in models of a
Introduction Target candidate description
d1.awsstatic.comInstrument application source code to enable tracing in AWS X-Ray 5.2 Perform root cause analysis on faults found in testing or production. Interpret the outputs from the logging mechanism in AWS to identify errors in logs Check build and testing history in AWS services (e.g., AWS CodeBuild, AWS CodeDeploy, AWS
Understanding Motion Simulation - SolidWorks
www.solidworks.comMotion simulation for mechanism analysis and synthesis Suppose an engineer is designing an elliptic trammel meant for tracing differ-ent ellipses. When he has defined mates in the CAD assembly, he can animate the model to review how the …
THE AMERICAN SOCIETY OF ECHOCARDIOGRAPHY …
www.asecho.orgfocused view) tracing the endocardial – blood pool interface (between the compacted myocardium and the cavity) at end-diastole and end-systole on images with clear endocardial border definition. Papillary muscles should be excluded from the cavity tracing. Maximize LV area and avoid foreshortening.
THE ROLE OF TRANSPORTATION IN LOGISTICS CHAIN
archive.siam.orgThis analysis shows transportation is the highest cost, which occupies 29.4% of logistics costs, and then in order by inventory, warehousing cost, packing cost, management cost, movement cost and ordering cost. The ratio is almost one-third of the total logistics costs. The
SARS-CoV-2 variants of concern and variants under ...
assets.publishing.service.gov.ukApproximately 9,000 samples are pending analysis and for approximately 2,400 samples variant assignment is not possible. This issue resulted in a reduction in genome coverage for specimen dates 10 to 15 June 2021 and . SARS-CoV-2 variants of concern and variants under investigation 4
Higher Order Thinking Skills Question Templates
medicine.wright.eduReview a book, performance, or exhibit. Justify your evaluation. Which _____ is the best? Why do you think so? Whose arguments/evidence was more convincing? Why? If you were the judge, what would your decision be? Why? Give and justify your opinion on _____ .