Risk Management: A compliant Risk Management process comes in many forms. The key is to tailor your Risk Management program to align with your company needs including company size, budgets, and organizational maturity. Finding the proper balance for your company, your Quality Management System and associated Medical Devices is what OPTIM Associates excels.
Usability / Human Factors Engineering: OPTIM Associates assesses and mitigates Risks caused by Usability problems associated with Correct Use and Use Errors (i.e., Normal Use) as it relates to Safety of a Medical Device for the patient, user and others. We have deep expertise and extensive experience developing and implementing Usability Engineering programs tightly integrated with Risk Management that reduces and/or eliminates regulatory exposure while increasing bottom line returns and organizational efficiencies.
Software Development Life Cycle: Software Hazard Analysis is a process which applies to the development and maintenance of Medical Device Software when the software is itself a Medical Device or when software is an embedded or integral part of the final Medical Device.
As stated in IEC 62304, Medical Device Software – Software Life Cycle Processes, Risk Management provides a management environment that lays a foundation for an organization to develop safe and effective products.