Industry Regulations in Medtech: Maintain Compliance with Regular Risk Assessments 

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The MedTech industry is regulated by complex guidelines to ensure the safety, efficacy, and security of medical devices and technologies. Key regulations include the Food & Drug Administration (FDA), ISO, IEC, General Data Protection Regulation (GDPR), the California Consumer Privacy Act (CCPA), and the Health Insurance Portability and Accountability Act (HIPAA). Understanding these regulations and the legal ramifications of non-compliance is crucial for success of all MedTech companies, suppliers, vendors, and partners to mitigate risk, fines, penalties, and lawsuits.