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Revision of European legislation on medical devices
Nov 5, 2015 ... Environment, Public Health and Food Safety of the European .... notified bodies the EMA (European Medicines Agency) must also be involved ... Furthermore the additional provisions lay down that the special notified bodies initially report ... " Conformity assessment based on a quality management system ...
[ revision_eu_gesetzgebung_medizinprodukte_EN.pdf - Read/Download File

New Medical Device Regulation (PDF)
Jun 27, 2016 ... Device Identification, general safety and performance requirements, ... consultation of the EMA, the ECHA and the EFSA, as relevant. ..... have a quality management system and a post-market surveillance system in place which .... manufacturers to report serious incidents and other reportable events and to ...
[ 06-27_MDR.pdf - Read/Download File

New IVD Regulation (PDF)
Jun 27, 2016 ... consultation of the EMA, the ECHA and the EFSA, as relevant. .... management and a system for reporting incidents and field safety corrective actions. .... manufacturers to report serious incidents and other reportable events ...
[ 06-27_IVD.pdf - Read/Download File

Guideline DD/TF NAM - TÜV SÜD
Risk Management file, Clinical Evaluation Report, etc.). A complete ..... states or the EMA regarding the assessment of usefulness and safety applied to a me-.
[ guidance-design-dossiers.pdf - Read/Download File

Med-Info Design Dossiers - TÜV SÜD
Medical Device Nomenclature System and/or Global. Medical Device ... Most important technical data (to be specified), reports, attachments ... Chemical, physical (mechanical safety and performance) ... competent bodies of the member states or the EMA regarding ... Aseptic filling: Validation plan, risk management strategy ...
[ design-dossiers.pdf - Read/Download File

Overview of comments received on draft guideline on the
TÜV SÜD (TS). DE ... A formal report will be prepared and published in the European Heart Journal. .... the EMEA regarding the assessment of usefulness and safety of the ... Guideline on Risk Management Systems for Medicinal Products for.
[ WC500003279.pdf - Read/Download File

Cook IVF Cell Culture Media - European Medicines Agency
Aug 8,[email protected] Website ... Consultation procedure Public Assessment Report (CPAR) ..... The viral safety of Human Serum Albumin 25% has been .... 13485:2003 certified by TUV SUD product service. ... The quality management system standard imply periodical audits.
[ WC500130866.pdf - Read/Download File

Situation update of the controls regarding the poly implant - ANSM
controls were performed by the notified body (TÜV) chosen by the Company. Between ... the management of the patients with PIP breast implants. Following ... vigilance. o From 2000 to 2003, 30 vigilance reports regarding PIP silicone implants, .... o The certification system of compliance with the safety and health essential.
[ e507413b331bf582f571262602893719.pdf - Read/Download File

Doing Business in Singapore - International Trade Administration
Technical Barriers to Trade (TBT Agreement) to report to the WTO all proposed technical regulations that could affect ... Occupational safety and health management system (OSHMS) certification bodies. Hazard Analysis and .... Energy Market Authority (EMA) ... TUV SUD PSB Pte Ltd (previously PSB Corporation Pte Ltd).
[ Singapore.pdf - Read/Download File

Medical Devices Regulations & requirements in - SIPSMENA
1.1 European Union definition (EMA). .... that fails minimum quality and safety standards; or simply no trace of what ... for the identification of devices involved in adverse incident reports. ... management system and the conformity assessment procedures for the .... and TÜV, play an active role in the medical device industry.
[ Medical-Devices-Regulations-requirements-in-Europe-USA-Jordan-Saudi-Arabia.pdf - Read/Download File

Download the white paper (PDF) - BSi
Oct 5, 2015 ... for medicinal products.6 The EMA will explore making its approval process less .... responsible for management of technical files and Declaration of Conformity and for .... post market surveillance system, periodic safety update reports and ..... Notified Body Auditor for NEMKO (previously for NSAI & TÜV PS).
[ WP-EU-MedRegs-updated.pdf - Read/Download File

EU Recast of the Medical Device Directives - CROMSOURCE
governing the safety and performance requirements of medical devices were ... had to be transferred into the national legislative systems of all EU member states . ... development and life cycle management of medical devices as well as .... reports, and collected around 1000 amendments on the draft regulation (9.8, 9.9,  ...
[ EU-Recast-of-the-Medical-Device-Directives.pdf - Read/Download File

Medical devices: the myths and the truth
improve patient safety is a concern of patient organisations, physicians, and ..... Whenever there are reports of adverse events or defective medical devices, .... Results of total hip replacement using the Robodoc surgical assistant system: clinical ... practice management of insurance funds and the principles of managing ...
[ thesenpapier_gross_0913_engl_1.pdf - Read/Download File

September 2013 - APLAC
Nov 1, 2013 ... ... The Board of Management has not met since our last report but will do so on 7 and 8 September. .... SGS, TUV formerly Moody International ..... PAC MLA food safety management system as the first country ...
[ aplac_news_notes_116.pdf - Read/Download File

HKAS News Issue No 56
Risk management for patient safety is a new .... the ILAC/IAF combined mark on the reports is not .... FHKI, TÜV Rheinland HK Ltd., VTC and HKSTP). ... The ISO 14001: 2015 “Environmental management systems – Requirements with ... Denmark, EMA Mexico, ENAC Spain, ESYD Greece, INAB Ireland, IPAC Portugal ,.
[ hkas_news_056.pdf - Read/Download File

Legitimacy, credibility and responsibilities of the (big - Hal-SHS
Jan 21, 2016 ... certificates of conformity with the “essential safety requirements” that industrial ... and show how the “notification system” has helped some private ..... Toulon held the German certifier TÜV Rheinland liable for having ... was essentially to audit PIP's management system without having to inspect the breast.
[ document - Read/Download File

Summary of Main DRUID Results
Jan 24, 2012 ... EMA. European Medicines Agency. ES. Spain et al. et alii (Latin): and ... International Council on Alcohol, Drugs & Traffic Safety ... report and all deliverables are available on the DRUID website ...... o The importance of implementation of quality management systems ..... TÜV Rheinland Consulting GmbH.
[ 2012_Washington_Brochure.pdf?__blob=publicationFile - Read/Download File

DRUID Final report
International Council on Alcohol, Drugs and Traffic Safety. ICT. Information ... Quality Management System. QRD. Quality Review of Documents. PhVWP. EMA Pharmacovigilance Working Party. PT .... TÜV Rheinland Consulting GmbH. TRC .
[ Final_Report.pdf?__blob=publicationFile - Read/Download File

Newsletter - ISA
Aug 7, 2013 ... provides unbiased testing reports of instrumentation. In the low-bid environment many of .... systems, and enterprise asset management systems (EAMS) as ..... Narciso Santiago, EMA. Save Time ... E. Earl Eiland, TÜV SÜD AG. Wireless .... development for Siemens' process automation and safety products ...
[ ISA-WWID_newsletter_2013spring-summer.pdf - Read/Download File

WHO Expert Committee on Specifications for Pharmaceutical
and control, the development of equitable health systems based on primary ... The WHO Technical Report Series makes available the findings of various .... WHO guidelines on quality risk management. 29 .... European Medicines Agency (EMA) ... Mr M. Deats, Quality and Safety: Medicines, Essential Medicines and Health ...
[ TRS-970-pdf1.pdf - Read/Download File

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