5 Ways FMEA MEDICAL DEVICE Will Help You Get More Business

FMEA Risk Management Tool

The Failure Mode & Effects Analysis (FMEA) are important techniques applied in quality management. It is used to prevent errors, improve product quality to eventually increase product safety. Medical device manufacturers compulsorily apply it while in production. Other economic sectors such as the aerospace, automobile industry, etc. also implement the FMEA method for commercial benefits.

Different aspects of FMEA contribute to avoid the general errors,also increase operating reliability of medical devices. Through early testing, detection and elimination techniques one can easily find potential weak points.

Medical devices manufactured with FMEAensure first-error security and so the risk is reduced at an early stage. Apart from the product safety, there are some economic benefits of an intensive FMEA implementation:

• Reduce errors in the manufacturing as well as product use.
• Avoid undesirable development, duplication of work and save development time.
• Eliminate repetitive errors.
• Reduce serious accidents and productivity failures.
• Enhance quality awareness in employees.
• Improved exchange of information, skills, and experience.
• Increase cross-departmental cooperation.

With long years of great experience in a hi-tech regulated industry, Orcanos is assisting medical device manufacturers including other high-tech industries in building their operational excellence. Their CAPA and FMEA Medical Devices allowclients to manage their work, improve quality and productivity. Streamline compliance regulations such as IEC 62304, ISO 14971, andISO 13485 are better complying with regulatory authorities like FDA and CE.

Applications designed by Orcanos facilitate various key features such as easy access, smart dashboards, real-time alerts and many other through which customers can track progress of their ongoing projects.

The company founded byRami Azulay and Zohar Preezt in the year 2005.Orcanos is the only business inarea that helps their clients to implement integrated ALM (Design Control) software & Quality Management (QMS). The company also provides industry-based regulatory compliance and specializes in medical device industry.

You can select FMEA risk management, security and management plans as per your need by visiting website https://www.orcanos.com/compliance/fmea-risk-management-iso-14971/ Talk to their experts, call on +972-3-5372561 or share your queries at info@orcanos.com