As an ISO 13485-certified tech partner, we know how to meet the requirements of the FDA and the Council of the European Union. We have hands-on experience with HIPAA and GDPR compliance. Our team of regulatory consultants, security engineers, and healthcare software developers can evaluate, implement, or improve the administrative and technical safeguards as required by these regulations. We are also ready to guide you through HIPAA/GDPR risk assessment and FDA/CE/MDR/IVDR submission process.