REGULATORY SERVICES
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.
Click here to download our Regulatory Services Flyer:
“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.”
Paul DiPerna
CEO of Modular Medical
Founder of Tandem Diabetes
“Thank you, BeanStock Ventures, for the successful collaboration in software development and managing a highly complex program. We were impressed with the successful integration of your experts with our Research and Development team and the achievement of end-to-end integration in six months. Your creation of a custom team to complement our team and provide the leadership in software strategy; designing our interface and leading the integration of the secondary analysis software and planning for a new life science instrument across four organizations was professional, effective and aligned with our business needs. I would highly recommend partnering with BeanStock Ventures on innovation and software product development in life sciences, biotechnology or medical devices.”
Mimi Healy
Former CEO
Lasergen, Inc.