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.
BeanStock Ventures is a FDA-Recognized 510(k) Third Party Review Organization which means we can review select 510(k) device submissions on behalf of the FDA. This program saves you time and money by allowing you to clear your devices faster than the typical FDA processing time can be up to six months.
The 510(k) Third Party Review Program provides medical device manufacturers with a voluntary alternative review process, in which accredited Third Party Review Organizations (3P510k Review Organizations) such as BeanStock Ventures are allowed to review select medical devices while still maintaining FDA oversight.
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The Software Online/Onsite Agile Regulatory (SOAR™) Training will assist the organization, team and engineer in implementing the right strategy for their Agile software teams. It has been designed to maintain the team’s agility while:
Training will be conducted by subject matter experts and will consist of sixteen 90 minute on-demand classes. In addition to the 24 hours of class training, you will also receive 24 hours of Q&A with our experts (one hour a week for six months).
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Leverage our time-tested (and time-saving) tools, processes, procedures and methodologies for ensuring compliance.
Prefer something custom made? We can work on your existing procedures and tools, create new ones just for you or modify your existing framework to adapt to your unique team and business needs.
We prepare your design history to meet all of your markets relevant compliance standards and ensure that nothing gets overlooked.
By providing a thorough audit, gap and risk assessment of your current processes, we eliminate the risk of non-compliance.
We modify existing or acquired product design histories in order to bring them up to current regulation standards.
Our compliance team makes sure that all tools used in development are fit for purpose.
Reach out today for your FREE product assessment.
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