User Needs / Design Inputs

SIM Solutions has world-class expertise in medical device systems engineering best practices. We start by helping clients define requirements and use cases based on user needs. As design concepts begin to mature, we facilitate design trade studies and human factors evaluations.

Risk Management

Throughout the product development process, we work with clients to perform medical risk management activities including risk analysis, software hazard analysis, design failure modes, effects, and criticality analysis (DFMEA / DFMECA), risk-benefit analyses, use / misuse analysis, safety assurance case arguments, and overall residual risk assessments. We ensure products are developed from start to finish with an emphasis on patient and user safety.

Model Based Systems Engineering (MBSE)

Our staff is experienced with the latest Model Based Systems Engineering (MBSE) tools and techniques using the MagicDraw (Cameo Systems Modeler) SysML environment to deliver model based requirements and architectures quickly and efficiently, with full top to bottom traceability. Our novel implementation of integrating risk management into a MBSE environment won our client Best Use of MBSE/SysML by No Magic in 2013.

Verification and Validation (V&V)

As hardware and software is designed and built, we support verification and validation (V&V) activities using a risk based approach. SIM Solutions will write test protocols, test cases / scripts, unit tests, and perform testing activities using our staff and/or the clients’ staff, while maintaining the level of independence required by regulations. As design transfer activities begin, we work with manufacturing and service organizations to validate manufacturing processes and test fixtures by writing and performing IQ / OQ / PQ qualification tests. We also have experience creating automated tests using LabView to reduce operator-induced variability and significantly reduce the number of testers required to execute labor-intensive tests.

Prior to product launch, we assist with design history file requirements needed for Class II and Class III medical device regulatory submissions for 510(k) or PMA approval. Our staff is also experienced with managing medical device projects, improving design control processes, lifting FDA warning letters, or helping clients lift consent decree requirements.

Regulatory Support