Compliance Areas

FDA Medical Device Clearance & Compliance

The FDA has comprehensive compliance and clearance requirements. We use GxP best practices to customize regulatory strategies, provide hands-on assistance with FDA submissions, establish tailored Quality Management Systems (QMS), act as a liaison with the FDA, and assist in maintaining regulatory compliance post-market.

EU MDR & IVDR

The European Union has introduced stringent medical device and in-vitro diagnostic compliance and certification requirements which cover similar requirements to the U.S. FDA and touch on hardware, firmware, and software. These must be complied with to market products in the European Union.

AI Governance

As AI/GenAI are becoming widely used, it is essential to put in place governance that ensures appropriate use of these technologies and protects against emerging compliance requirements related to accuracy, IP ownership, confidentiality, data governance, cybersecurity, and other risks. These concerns are leading to regulations on the use of AI and GenAI.

Privacy

Privacy regulations are being increasingly enforced. Worse the regulations vary across countries and U.S. states. Regulations like GDPR, CCPA, and LGPD must be complied with, an undertaking that requires all aspects of policies, processes, training, and technology.

Healthcare

Healthcare has many security, quality, and regulatory requirements. In the U.S. HIPAA is a core requirement. Compliance with CMS Medicare regulations (MIPSS/QPP) has substantial revenue impact. Quality reporting is required by different federal agencies and private insurers. Other countries have their own regulations.

Security

Security is a foundational requirement for quality and regulatory compliance. Your organization must have robust technology security in place using standards and frameworks such as ISO, NIST, and SOC. In addition, you need sufficient performance and business continuity to meet business requirements.