Medical Device Regulatory Compliance Services

Regulatory Submissions and Documentation:

• Preparation of 510(k), PMA, De Novo submissions
• Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA)
• 505(b)(2) applications
• Clinical Evaluation Reports (CERs) and Biological Risk Assessments

Technical Writing for Quality Management Systems (QMS):

• Development and documentation of ISO 13485 and ISO 9001-compliant procedures and manuals
• Standard Operating Procedures (SOPs) and work instructions
• Risk management documentation (ISO 14971)

Labeling and Product Documentation:

• Creation of Instructions for Use (IFU) and user manuals
• Labeling content development in compliance with regulatory standards
• Unique Device Identifier (UDI) labeling and submission support

Postmarket Surveillance and Reporting:

• Adverse event and complaint reporting
• Postmarket surveillance plans and reports
• Vigilance reporting for EU MDR

Clinical and Nonclinical Study Reports:

• Writing and submission of clinical study protocols and reports
• Preparation of nonclinical study documentation, including toxicology and biocompatibility studies

Regulatory Strategy and Compliance Support:

• Global regulatory strategy development and planning
• Gap analysis and remediation planning for FDA and EU MDR compliance
• Technical File and Design Dossier preparation

Training and Consultation:

• Custom training sessions on regulatory documentation best practices
• Consultation on technical writing standards for regulated industries