With a new emphasis on risk management, regulators expect you to have a robust system. Can your system stand up to scrutiny or will it wilt when exposed to bright light?
Medical device manufacturers implement a Quality Management System (QMS) as part of the regulatory requirements. For products marketed in the EU and Canada, manufacturers use ISO 13485. For products marketed in the US, the requirement is FDA QSR. Both systems stem from ISO 9001 concepts. A critical element of medical device quality is Risk Management. The basic standard is ISO 14971.
This training covers the essential elements of a medical device quality management system involved in creating an effective Risk Management system. Using the GHTF guidance document for a framework, the seminar covers the QMS essentials (ISO 13485 & QSR) that have the most direct impact on Risk Management. These QMS activities include product planning, design and development, supplier management, process validation, customer complaints, internal quality audits, corrective action, preventive action, and post-market surveillance. In addition, the seminar clarifies the requirements for verification and validation. The material compares and contrasts ISO 13485 and FDA QSR requirements.
ISO 14971 specifically covers Risk Management activities for medical devices. This standard, recognized by the EU, Canada, and the US, provides the structure for Risk Management. The seminar takes the participants through the requirements of the standard with a focus on both effective implementation and integration into the QMS. Participants will learn the skills from establishing a risk matrix for your product to implementing post-surveillance monitoring. The seminar discusses tools for Risk Management including: FMEA (Failure Modes and Effects Analysis), FTA (Fault Tree Analysis, and HACCP (Hazard Analysis and Critical Control Points).
Topics include the Risk Management elements of the US, EU, and Canadian regulatory systems. These include risk classification for medical devices, complaint management, and adverse event reporting. In addition, the training discusses the Global Harmonization Task Force (GHTF) guidance document, Implementation of Risk Management Principles and Activities within a Quality Management System.
Added by complianceonlinecom on March 29, 2011