Regulatory Affairs (RA)

Regulatory Compliance

RA professionals ensure that medical devices comply with relevant regulations and standards, such as FDA regulations in the United States, EU Medical Device Regulation (MDR) in the European Union, and other international standards like ISO 13485 for Quality and ISO 14971 for Risk Management.

Click the following link for more information on FDA Medical Device Regulation:

FDA 21 CFR Part 820 QSR

Click the following link for more information on EU Medical Device Regulation:

EU MDR Regulation 2017/745

Product Registration

RA manages the process of registering medical devices with regulatory agencies, which involves submitting comprehensive documentation, including technical specifications, clinical data, and manufacturing processes.

Labeling and Advertising Compliance

RA experts review and approve labeling, packaging, and advertising materials to ensure they meet regulatory requirements and accurately represent the device's intended use and safety information.

Quality Management System (QMS)

RA professionals work closely with Quality Assurance (QA) teams to establish and maintain a robust QMS, ensuring that all aspects of device design, development, manufacturing, and distribution comply with regulatory standards.

Post-Market Surveillance

RA Team monitors and reports adverse events, complaints, and device failures post-market, ensuring timely reporting to regulatory agencies and implementing corrective actions as necessary.

Quality Assurance (QA)

Quality Control

QA professionals develop and implement quality control processes throughout the manufacturing process to ensure consistency and reliability of medical devices. This includes inspections, testing, and documentation of materials and finished products

Risk Management

QA team conduct risk assessments and implementing risk management processes according to ISO 14971 standards. This involves identifying potential hazards, assessing risks, and implementing mitigation strategies to ensure device safety.

Audits and Inspections

QA teams perform internal audits to assess compliance with regulatory requirements and QMS procedures. They also prepare for and participate in external audits and inspections by regulatory agencies.

Document Control

QA manages document control processes, ensuring that all documentation related to device design, manufacturing, testing, and distribution is accurate, up-to-date, and accessible to authorized personnel.

Training and Education

QA provides training to employees on quality policies, procedures, and regulatory requirements to ensure a culture of quality and compliance throughout the organization.

Key Responsibilities

Regulatory Strategy Development: Developing strategies for product registration, market entry, and compliance with changing regulatory landscapes.
Clinical Trials Oversight: Ensuring that clinical trials are conducted ethically and in compliance with regulatory requirements, including obtaining necessary approvals and reporting trial results.
Post-Market Surveillance: Monitoring device performance in the market, addressing complaints, and implementing corrective and preventive actions (CAPA) as needed.
Labeling and Packaging Compliance: Ensuring that labeling and packaging meet regulatory requirements, including symbols, warnings, and instructions for use.
Quality Management: Establishing and maintaining a comprehensive QMS to ensure consistent product quality, safety, and efficacy.