Regulation compliance might not be glamorous, but it is absolutely essential, particularly when dealing with the healthcare industry.
When developing new products, it can be easy to focus more on the technical or design side than the various rules and regulations, but failure to address the fine print early is something that can have major legal and financial repercussions later on.
Our team ensures that your products comply with all major international regulations (FDA, IEC 62304, ISO, GDPR, HIPAA) and can evaluate the requirements of other regulatory standards as required for your product and market. We keep track of changes and future developments to regulations within the United States and internationally, to ensure your product will comply to current and future landscapes. On top of this, we have extensive international experience and can ensure that your products comply with regional regulations with short notice, causing little to no disruptions to your schedule.
We can handle all of your regulation compliance in-house or train your team to perform the required checks moving forward.
“Thank you, BeanStock Ventures, for being a key and valued contributor to the success of our recent 510K submission. The collaboration with our regulatory, quality partners and product development team could not have gone better. BeanStock Ventures deep understanding of the medical device industry and regulatory landscape helped deliver a professional, thorough software process and thereby a finished product for submission. Your careful oversight and guidance aligns with our corporate objectives and allowing us to achieve our key milestones. We look forward to working together on our future software quality and regulatory needs.”