GHP / Q3 2021 53 The Company Ensuring Oversight inMedical Device Trials service provision ensures that the budding sector has a stalwart cheerleader in its corner, encouraging businesses both new and established towards better ways of working that will benefit both them and their end users, as well as the industry at large. After all, working on the implementation of compliance and developing better ways to conduct clinical trials for medical devices will result in better results across the board, as well as more reliable ways of working that will improve the reputation of medical device development. It also has experience working with companies of all scales in its sector. Whether a client is a small, start-up business, only just leaving the starting blocks, a medium company making its way, or a large, enterprise level business looking for a new way to ensure regulatory compliance is being upheld, Key2Compliance is confident that it has the answer. Fundamentally, it is able to ensure that each individual company is treated as though they are Key2Compliance’s only client. In short, the benefit to this is the benefits it can directly pay forward to the client, working on an in-depth and interpersonal level with them in order to guarantee correct and wellfounded clinical development. It promises to always be in the client’s corner throughout their forays into the medical device creation and testing world, making itself the flexible and adaptable solution for professionals that let a client’s buyers purchase devices with confidence. Additionally, any and all clinical development plans that it makes will be sure to work seamlessly with a client’s existing operations. By creating something that works in harmony both with the legislation and regulations that govern the industry, as well as that client’s internal goals, principles, and values, it leads from the front in changing medical device compliance assurance for the better. Moreover, Key2Compliance knows how to handle medical devices across all risk classes both before and after launch. The impetus behind this is that there is no job too big or too small for this company, and if a client already has clinical data available on a product, it can work with that too, collecting and evaluating this data in order to compare it to the relevant regulations. After compiling this information, it will present the clinical report that results to the client, working hard to untangle the numbers and see the story behind them, discerning the need for any post-market clinical follow ups. The clinical evaluation report is the foundation of the clinical development plan for a client’s product. This is essential to get right, and so Key2Compliance has funnelled significant effort into upholding its promise that nothing about this report is left to chance, every element being handled with the utmost scrutiny to allow itself to become the partner a client can rely on. Going forward, its team of project management specialists, monitors, CTAs, statisticians, data managers, regulatory managers, medical advisors, and medical writers will be continuing their exemplary efforts in aiding medical device oversight, supporting its clients through its local and global network. Company: Key2Compliance AB Contact: Jan Hellqvist Website: https://key2compliance.com/
RkJQdWJsaXNoZXIy MTQxNTg3MQ==