A changing regulatory landscape
The reality for companies involved in the development of medical devices and in vitro diagnostics is changing. New regulations for medical devices (MDR) and in vitro diagnostics (IVDR) generate completely new requirements on documentation, data and quality management. At the same time, the product life cycle has become shorter and competition between products and companies has increased. In addition, the requirements for the provision of financial means are higher than ever before. Therefore, today it is even more important than before to do the right thing from the beginning and even further, during the entire development process.
Choose the right partner, for a seamless product journey
That is why we think you would benefit from partnering with Key2Compliance® during all steps of your product development process. We offer complete solutions that solve any challenges you may encounter in the development process, as we master all parts of it. We are specialized in the medical device industry, including in vitro diagnostics, and therefore we can operate your clinical development in a way that a “regular CRO” cannot do. We can help you develop the regulatory and clinical strategy by performing early GAP analyses. We can assist you in creating a quality system that works overtime. We can plan and run your biological evaluations and toxicological studies. In addition, we help you with registration and/or CE marking, risk management and audits, and not least we provide top-class training and education to keep your staff up to date with all regulations.
Complete and tailor-made solutions in a one-stop shop
So, who are Key2Compliance®? Well, many of you already known us as Symbioteq. But since Symbioteq acquired the training specialist Key2Compliance®, we are now operating under the same name – Key2Compliance®. The new company has an even stronger position and our offering is reinforced in several ways. We can proudly say that we offer the most complete and comprehensive educational service on the market. Another new feature is that we now also offer clinical development for the medical device industry. This makes us the “one-stop shop” for everything that has to do with development of medical devices.
It is the team that makes the difference
Our most important asset is our dedicated staff. Our team consists of specialists from all over the world, with long and broad expertise in all aspects of the development of medical devices and in vitro diagnostics. They form the basis from which we customize your team based on your needs. Should we support your existing organization with individual competencies, or should we take full responsibility? It’s entirely up to you. We are 100% flexible and we are passionate about your business and the safety of all patients.
We are located in Northern Europe but operates worldwide
You can find us in the Stockholm/Uppsala region as well as in Gothenburg and Malmö/Lund. But even though our customers today mainly come from Sweden and Denmark, we have customers from other parts of the world, such as the USA and Asia. It is our absolute ambition to grow. Both in the Nordics and in other areas.
Let me conclude by once again emphasizing the importance of choosing a partner who understands Life Science and especially the medical device industry and in vitro diagnostics. One that knows the specific regulations and processes applicable to the this industry. Because it differs a lot from the regulations applicable to the pharma industry. You might lose a lot of time and waste money if you choose the wrong path from the beginning.
Hence, we want to welcome all new and old customers to Key2Compliance®. You can rely on us; we have all the keys needed for a successful development journey. We make complex things easier from idea to market.
Jan Hellqvist, CEO