This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices. It serves to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device. This International Standard does not apply to clinical decision making. This standard does not specify acceptable risk levels. This standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system. This new edition of DIN EN ISO 14971 was required due to the European new edition EN ISO 14971:2012 containing with respect to the previous edition updated Annexes ZA, ZB, ZC and a correspondingly adapted European Foreword. The main part of the standard containing the translation of ISO 14971:2007 (corrected version of 2007-10-01) has not been modified in this new edition. The International Standard ISO 14971 has been prepared by Technical Committee ISO/TC 210 "Quality management and corresponding general aspects for medical devices" (secretariat: ANSI) in collaboration with CEN/CLC/TC 3 "Quality management and corresponding general aspects for medical devices" (secretariat: NEN) with the participation of German experts. At DIN, the German Institute for Standardization e. V., the committee responsible for this standard is Working Committee NA 063-01-13 AA "Qualitätsmanagement und entsprechende allgemeine Aspekte für Medizinprodukte" ("Quality management and corresponding general aspects for medical devices") at the Medical Standards Committee (NAMed).
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Quality Management & Regulatory Affairs Medical Devices & Combination products
Since 1994, effective Strategic & Operative experience in Quality Management & Regulatory Affairs for Medical Devices industry, within the fields of Ophthalmology, Neuro-stimulation, Vascular Intervention, Cardiology, Heart Surgery, Orthopedics, Dental Care, Modern Wound Care, Regional Anesthesia, Minimal Invasive Surgery, Navigated Robotic Surgery, CT & NMR digital Imaging (3D), and in vitro Diagnostics.
Technical Documentation (DHF, DMR, DHR) including Analysis & Evaluation of Product Function & Safety, Biocompatibility, Packaging, Labeling (UDI), Sterilization, Laboratory results, Software & Hardware.
Compliance to applicable Standards (ISO, IEC, EN, MIL).
Manufacturing Process Verification, Validation (IQ, OQ, PQ).
Product & Production-process Risk Management (Risk Analysis & Risk Control), including Additive Manufacturing.
Clinical Evaluation, Organization of global multicenter Clinical Studies.
Audits of Production Processes & Suppliers.
Medical Device Reporting to Competent Authorities (e.g. BfArM, FDA).
Corrective And Preventive Action (CAPA) / Non-Conformity (NC) / corrective Project.
On site Support in Notified Body audits, and FDA inspections.
Effective management leading to a multitude of marketing approvals in the EU, Americas (FDA), & Asia, including Reimbursement schemes.
Dr. Hekmat CONSULTING
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