The Baymar team has experience building prototype platforms and executing feasibility testing to determine if your concepts are going to function as intended. We can develop benchtop platforms to test subsystems or build the entire concept using our in-house pilot line.
The scientific and academic background of our scientific team allows us conduct thorough literature reviews for a variety of applications, such as: concept identification, identification of possible compatibility issues, establishing scientific and clinical background of IVD methods for regulatory purposes, among others.
The Design History File is a critical component of your device documentation. It can be a daunting task to put this together and ensure it is complete. We can help guide you through this process and support you with the technical documentation required to make this complete.
The Baymar team understands the hazard analysis, design FMEA, process FMEA, and service FMEA and can lead or participate in these important risk analysis meetings as contributors or independent reviewers.
All projects at Baymar are managed using the Agile methodology. With an Agile team mentality, Baymar can adapt to project changes in a quick, effective manner. We do this by emphasizing stakeholder involvement and communication.