If you're developing software that needs to meet FDA or HIPAA requirements, B.K. Schwarz Partners can provide you with expertise that will ensure compliance with the regulations, while balancing effective product development practices to minimize time to market.

Software Process Consulting

Many companies are expanding their product lines into the healthcare industry in order to leverage their existing technologies into new, growing markets.  The constant expanse of the healthcare industry in the U.S. has created enormous opportunities for biomedical and healthcare products.  But are you ready to address the challenges that come with this market, including compliance with FDA and HIPAA regulations?

B.K. Schwarz Partners can provide you with the expertise you need to navigate these regulated environments, in a way that allows you to concentrate on your business rather than on the regulations.  Our focus is not just on compliance with the regulations, but on doing so in a way that leverages your existing product development procedures to minimize time to market.

We have a set of SOPs, templates and forms, which can be quickly customized to your environment.  These provide compliance to the FDA QSR (21 CFR 820), Electronic Records (21 CFR 11), and IS09001.  In addition, we have expertise in 510(k), PMA and IDE development and submission, allowing you to focus on the development, marketing and sales of your product, rather than the regulations.

Application Development and Integration in FDA and HIPAA Regulated Environments

Our combination of experience in application development and FDA/HIPAA regulated business areas put us in a unique position to design, develop and implement technology solutions within a regulated environment.  Regulatory compliant systems include design elements that specifically address mandated requirements such as activity auditing, electronic signatures, and role-based security. We thoroughly understand these technical constraints and design compliant systems from the ground up. Critical elements are deeply embedded in the design to support validation and compliance from the initial implementation through the entire systems life cycle. And our proven project management and development methodologies deliver your compliant system on time and on budget.

FDA and HIPAA Regulated Infrastructure Security Consulting

Most organizations use software products to help automate their daily operations. Practice Management Systems, Electronic Medical Records, and other critical business systems must meet certain technical requirements to comply with the HIPAA Security Rule. You might be waiting for a statement of compliance from the software vendor and feel that would be sufficient for compliance. However some aspects of the HIPAA Security Rule put the burden for compliance back on you. You must ensure adequate security in your specific operating environment and then periodically re-verify compliance. Out experience in developing medical software systems provides a depth of understanding of practical ways to meet the requirements of federal regulations. B.K. Schwarz Partners can help you sort through the options and decide the best method for determining HIPAA Compliance Readiness and implementing HIPAA Compliant Technology Solutions.