Strategy
Regulatory – Taking into account the various geographies you plan on selling your device (i.e. your marketing strategy), you’ll want to figure out what regulations and standards will be required. This information will feed into your overall risk management and product design requirements. It may also impact your initial marketing strategy is feasibility is questioned. Trust us, you want a Regulatory Plan from the beginning or you’ll have lots of repeat work.
User Interface Requirements
User Needs – Start with defining your end user so you can understand their needs. It’s best to get as specific as possible during this assessment so that you can make sure the device meets a real need for a real human being. Ask yourself the following questions: Why am I making this device? Who will be using it? Why do they need it? What can I do to make sure this device will make their lives better, easier, and healthier?
Product Risk Analysis
You’ve got a great product development team, but they are wrapped up in making converting their prototypes to investigational devices. We can help you begin work on identifying and ranking all of the reasonably foreseeable risks in both normal and abnormal conditions; under proper use and foreseeable misuse. Better, we can be advocates in mitigating design features, remediation through process controls, and labeling.
Development/Remediation – Maybe you don’t have a quality management system yet. Or, maybe you have one but it needs some updating. You’ll need your QMS working and compliant before you go any further with medical device development. Use the audit/gap assessment to help drive resourcing and project timelines. And don’t forget to get certified!
QMS Gap Assessment
UDI And Labeling
Unique Device Identification - The world of UDI, territory specific labeling, and device registration is under constant change. We can assist in reviewing your current labels and helping you jump into the deep end of the pool with UDI for both the US and Europe.