Healthcare is a highly regulated industry. Regulatory compliance, as well as voluntary compliance with professional association guidelines is a fundamental requirement. “Move fast and break things” does not work in healthcare.
One of the first regulatory issues many early stage healthcare companies face is how to manage the information security and privacy requirements of the Health Insurance Portability and Accessibility Act (HIPAA). Significant financial penalties exist to encourage compliance. This requires a combination of policies, procedures, technologies, and roles that people in the organization play to ensure protection of the data. Fortunately, it is not that hard, but it must be attended to. Our consultants can help, based on experience working in many HIPAA-compliant organizations and in setting up new policies and procedures at several health startups.
Companies developing products that involve the diagnosis of human disease are regulated by the FDA. The Code of Federal Regulations volume 21 part 820 (21 CFR part 820) describes the requirements that a manufacturer must meet. It does not describe a specific quality system. Companies who make FDA regulated products can create their own quality systems as long as they meet the regulatory requirements. This is an opportunity to create a set of workflows that result in a documented chain of quality checkpoints. This is where our consultants and our affiliates can help.
FDA Regulatory Pathways
Our consultants have experience preparing 510k packages, and designing projects to create evidence of clinical effectiveness. Our network of affiliates can cover the full spectrum FDA regulatory pathway analysis.