I highly recommend Upshot as a trusted compliance partner for organizations navigating the complexities of medical device regulations. Throughout our journey at COVVI, Upshot has been instrumental in strengthening our Design Controls, aligning them with stringent regulatory expectations. Their expertise in Regulatory Strategy & Technical File Submissions has provided us with a clear and structured path towards compliance for both Medical Devices and Machinery. Their strategic approach significantly accelerated our market access in the EU, UK, Canada, Switzerland, and emerging markets. Upshot played a pivotal role in COVVI achieving ISO 13485 & ISO 9001 certifications. Beyond compliance, their structured methodology, regulatory insights, and commitment to excellence have made a real impact on our success. For any organization seeking a knowledgeable and reliable Quality and Regulatory partner, I wholeheartedly recommend Upshot. Their support has been invaluable to our success