Axeon offers organizations a complete curriculum of Medical Device Training Courses for certified auditor development that address key medical device sector regulations, as well as processes and systems that comply with these regulations.
Consulting, combined with training, coaching and guidance, supports your internal resources and ensures your organization understands what is necessary to drive for business improvement.
Achieve and maintain ISO 13485 certification with training from Axeon.
ISO 13485 is the system standard for medical device manufactures, suppliers and any other companies associated with related services. ISO 13485, the Medical Device Single Audit Program (MDSAP), and the ISO 13485 plus Current Good Manufacturing Practice (cGMP) cover the requirements for each applicable regulatory authority.
The EU Medical Device Regulation (MDR) is far more complex than the Medical Device Directive (93/43/EEC) it replaces and presents new challenges. Strict new requirements for Clinical Data, risk management, postmark surveillance and supplier management.
The EU MDR isn’t in effect until May 2020. Companies with limited resources and sizeable medical device portfolios often need help planning how and when to transition MDR.
Device manufactures have until March 2019 to update their cortication’s to ISO 13485:2016.
Axeon can support every phase of your transition to ISO 13485 and help you identify the improvement opportunities found in the revised standard.
CAPA impacts every aspect of your quality management system, from processes to products. Medical device organizations with effective CAPA programs identify problems, investigate root causes, document incidents, and refine their processes so that the problems do not reoccur. In addition, CAPA process yield information that is used to improve operations and financial performance.
Axeon consultants can perform an independent review of you corrective and preventive action system to uncover areas in need of improvement. We help you create an action plan based on this review that ensures you CAPA system is effective and efficient. We have been doing this for a long time, so we know how to apply best practices
ISO 14971 is an international risk management standard related to the manufacturing of medical devices. It is also recognized by most regulatory authorities as the ‘de facto’ risk management standard. ISO 14971 is a fundamental part of an effective quality management system and should be embedded into your manufacturing life-cycle process. A solid risk assessment program helps you identify design issues before distribution, eliminating dangerous problems and the costs of recalls.
Complying with ISO 14971 can be challenging. The standard requires you to review the risks associated by your device over time and monitor any changes (e.g. design, customer feedback, and post market surveillance). This level of risk assessment calls for special planning and appropriate staffing to support the necessary activities. Axeon can assist your development and implementation of needed processes efficiently and correctly while providing a valuable ‘outsider perspective’. The goal is to establish, document and maintain a risk management process to review the intended use of your medical devices, identify hazards and estimate the probability of occurrence, estimate the severity of each hazard, control the risks, and monitor the effectiveness of the control put in place.
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