Insights

The European Union Medical Device Regulation (EU MDR) has reshaped the landscape of medical device compliance across Europe. One of its critical requirements is the appointment of a Person Responsible for Regulatory Compliance (PRRC). This role is essential for ensuring that manufacturers meet the stringent demands of the regulation and maintain the safety and performance of their medical devices. Understanding the PRRC's role and responsibilities is vital for manufacturers,

Creating a clear and compliant organisation chart is essential for medical device companies and related industries. It helps define roles, responsibilities, and reporting lines, ensuring smooth operations and regulatory compliance. This post explains how organisation charts should be structured according to key standards: ISO 13485, EU MDR, Indian MDR-2017, 21 CFR 820, and MDSAP. It also highlights practical templates and examples to help you build or improve your organisatio

The medical device industry operates under strict regulations to ensure safety, effectiveness, and quality. One key regulation shaping this landscape is the 2017 Medical Device Rule. This rule introduced important requirements that manufacturers, importers, and distributors must follow to maintain compliance and protect public health. Since its implementation, there have been several updates reflecting technological advances and regulatory improvements. This post breaks down