As the “Best Clinical Development and Regulatory Compliance Firm” in 2021 for Sweden, Key2Compliance it making itself a partner to medical device creation companies. By making sure the clinical trials conducted on such products are thorough, comprehensive, and detailed, granting businesses the oversight they need to reassure buyers of the quality and compliance of their products, it has made itself the cornerstone of a budding industry.
Key2Compliance is a specialist company when it comes to the clinical development of medical devices. Fundamentally, it recognises that the clinical development of such products and services is highly different to that of pharmaceuticals, and therefore will need a specific service provision to aid the companies behind it. This is because the regulations and markets for such devices are so widely different; despite them both broadly landing in the wider industry of healthcare and health innovations, the legislation that The Company Ensuring Oversight in Medical Device Trials governs pharmaceuticals does not apply to medical devices, and vice versa, which can sometimes lead to confusion and stress on businesses.
Thus, Key2Compliance wishes to take this stress off of the client by helping them to navigate the deviations in regulations and requirements. In doing so, it also keeps a finger on the pulse of the medical device and diagnostic sector’s constant change and fluctuations. Additionally, Key2Compliance offers complete and totally comprehensive solutions that both acknowledge and work with the bigger picture, and zero in on the minute details. In this manner, it promises that nothing will go unscrutinised, allowing its clients to rest assured that they have a level of oversight in place that will make sure clinical trials are carried out safely, effectively, and to the letter of the legislations in place. Therefore, it seeks to work both with and for its customers.
In essence, this means that from the very beginning of relations with a client it will strive to develop and design a clinical programme that reflects both the company’s core values and upholds every element of the regulations and requirements they are required to operate with, guiding the client’s trial from start to finish. By working in such a collaborative manner, it fosters an atmosphere of teamwork both internally with its staff and between itself and its clientele, cultivating a network of professional contacts that each contribute to the other’s success.
Key2Compliance, in tandem with all of this, strives to be different. That is clearly evident from the manner in which it works, and a client can benefit from this from the very first meeting with its diligent and dedicated staff, each of whom has proven themselves time and time again as a professional and as a person. Its team know that in business, passion is what fuels those behind the scenes, and so each of them strives to truly connect with a client in order to gain an in-depth and empathic understanding of both their business model and the goals of their operation.
Therefore, it is 100% focused on clinical development for medical devices and diagnostics. This diligent and highly specific 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.
This article was published in GHP – Global Health & Pharma, Q3 2021.