Register for ASQ Southeast Florida’s March Section Meeting: Tuesday, March 14, 2023

This month’s section meeting will feature medical device expert Mercedes Massana as she goes in-depth into the world of integrated risk management in the medical device industry. The meeting will be hosted at Tropical Acres Steakhouse in Fort Lauderdale, FL and comes with a three-course meal. The price is only $5 for students, reimbursed at the door! Networking and registration begins at 5:30 p.m., dinner at 6:00 p.m. All ASQ Student Branch students are welcome. Register below.

Presentation Topic: Integrated Risk Management for Medical Devices

Risk Management is a very important part of developing a safe product and proving to regulators that it is safe and effective.  ISO 14971 Medical devices, Application of Risk Management to Medical Devices is a voluntary standard that medical device manufacturers must incorporate into their design and development process in order to ensure devices are designed safe and effective.  The FDA can audit to ISO 14971, if manufacturer’s claim they conform to it.  Although ISO 14971 has been in place since 1998, many companies still find it difficult to properly interpret the requirements of the standards and develop a compliant risk management process. In this session, you will see the risk management basics and how to integrate risk management processes into product development.

Presentation Speaker: Mercedes Massana, CEO, MDM Engineering Consultants

 Mercedes has over thirty-five years of experience in the Medical Device industry. She founded MDM Engineering Consultants, providing engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. She works with medical device companies to help develop and release products within the constraints of FDA/lSO Quality Systems, with focus on Systems Engineering and Risk Management. Mercedes is an ASQ certified Biomedical Auditor (CBA), Software Quality Engineer (CSQE), Quality Manager (CQMa), Quality Auditor (CQA), International Council on Systems Engineering (INCOSE) Certified Systems Engineering Professional (CSEP), and is Regulatory Affairs Professionals Society (RAPS) Devices Certified.