Services

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:

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“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.

WHAT’S INVOLVED?

(diy) DHF: Do-it-yourself SaMD/SiMD Regulatory Kits

Streamline your FDA or EU submission with our SaMD/SiMD regulatory kit. This (diy) kit includes a full set of design history file (DHF) templates and training that provides regulatory guidance aligned with best practices.

View our templates

3P510(k)

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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SOAR® Training

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:

Aligning quality and software to efficiently integrate Agile into the regulatory landscape
Advancing regulatory knowledge for real-world application
Establishing regulatory background and review requirements
Creating confidence in meeting aggressive product launches
Increasing ease in passing internal and external audits and inspections

Training will be conducted by subject matter experts and will consist of sixteen 90 minute on-demand classes.

Standard Procedures and Tools

Leverage our time-tested (and time-saving) tools, processes, procedures and methodologies for ensuring compliance.

Custom Procedures and Tools

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.

Design History Creation

We prepare your design history to meet all of your markets relevant compliance standards and ensure that nothing gets overlooked.

Regulatory Compliance

By providing a thorough audit, gap and risk assessment of your current processes, we eliminate the risk of non-compliance.

Design History Remediation

We modify existing or acquired product design histories in order to bring them up to current regulation standards.

Software Tool Validation

Our compliance team makes sure that all tools used in development are fit for purpose.