Healthcare is an industry where every stakeholder is regulated; the question is how much? Hence, the regulatory strategy for a venture is a product, target customer, and stage-specific. 

Imagine figuring out which will feature in your business - FDA, CMS, DHS, DEA, State regulators, Licensure and Credentialing authorities, and many more.

We develop a regulatory strategy that identifies optimal claims to make based on your business goals, market conditions, and core technology.

We set up quality management systems that comply with ISO 13485 and FDA 820.30 requirements.

For all stages of ventures, we intend to answer the complex question:

1. What regulations impact me?
2. In what situations will I not be regulated?
3. How can I build a moat via regulations?
4. How do my customers and the users of my product get regulated?
5. What reporting responsibilities do they have that would require me to fulfill as part of implementation?
6. What regulatory changes are on the radar? Headwinds? Tailwinds?
7. If relevant, what does it take to clear health technology assessments from my potential customers?

Our objective is to put together what creates the best path to launching the product and capturing value. Additionally, we consider the burden of post-launch quality and regulatory compliance while putting together the best options from a regulatory perspective.

To prepare the necessary documentation, we partnered with quality and regulatory experts with a history of successful clearances, approvals, and audits from the FDA. We partnered with experts who have successfully helped startups clear AICPA SOC2/ ISO 27001 compliance requirements. We dip into our ecosystem to find the appropriate regulatory partner who has previously achieved regulatory approval for a similar product.

‍

Pre-revenue

At this stage, your focus is on product and information security regulations.

We answer questions like:

1. Verification and validation testing based queries
2. What is the impact of the new regulations on human factors and the cybersecurity of my product?
3. What do I do if my product cannot fulfill specific claims? (we put on our product and business hats here)
4. What AI and IT regulations must I comply with for network-enabled products and when?
5. What is a good framework to evaluate PHI-enabled software infrastructure and API providers?
6. How can I inject design documentation into my product development process?

Launch and Growth

At this stage, you are facing the impact of your potential customers' needs and regulations while being able to balance maintaining your own quality and regulatory system.

Our focus becomes outwardly on ensuring:

1. Your suppliers and manufacturers meet the FDA quality and regulatory standards.
2. Your offering meets your customers' regulatory compliance requirements.
3. Your marketing and clinical communication meets the claims for which your product is authorized.
4. Improvement and updates to your product when necessary with the least regulatory burden (special 510(k)s, letters to file)

‍

‍

‍