The costs of compliance are also broken down over a longer time, and the risk of expensive, unpleasant surprises is mitigated when you have a better understanding of what to expect and what you still need to do.

Developing and launching a great idea requires a solid understanding of the current clinical picture in the therapeutic area you are aiming to address. A systematic literature review, with solid reasoning for the choice of search terms, databases, time-frames, inclusion criteria and data analysis is one of the essential puzzle pieces for building a clear picture of your device in the context of the state of the art. Understanding the measurable safety and performance parameters of competing solutions is necessary for benchmarking the performance and safety of your device. Identifying risks, as can be done from peer-reviewed literature, is key at every stage of a device’s lifetime, but the more risks you can identify and mitigate early on, the safer your device will be (and the lower your costs). Provable device safety is a must when trying to get your product on the market.

During device development, extensive pre-clinical and clinical testing is required to make sure your device does what you want it to do, in the best, most efficient, safest way. Some testing requirements are obvious from specific standards applicable to your device. However, simply following standards may not provide you with all the proof you need for your device, especially if you are developing a product based on new technology. Tailor-made plans for usability studies and clinical investigations cover your needs and anticipate what regulators may ask for as evidence to support your claims when the moment of certification comes.

And while you may not be ready to get your device certified yet, knowing what lies ahead and what you need to do to get there helps you plan better and allocate your resources accordingly. Having templates for clinical development plans, clinical evaluation plans and reports and other such documents gives you a clear picture of the steps you need to take to have your technical documentation ready. Not to mention it helps with your QMS.