Medical Device Compliance Services
Regulatory Strategy Development
- Guidance on FDA and international regulatory pathways
- Development of regulatory strategy and submission plans
- Assessment of device classification and regulatory requirements
Regulatory Submissions
- Preparation and submission of 510(k), PMA, and De Novo applications
- Assistance with international regulatory submissions (e.g., CE marking, ISO certifications)
- Coordination with regulatory bodies for approvals
Documentation and Record-Keeping
- Development and maintenance of required documentation
- Creation of technical files and design dossiers
- Management of clinical and preclinical study documentation
Quality Management Systems (QMS)
- Implementation and maintenance of QMS in compliance with FDA 21 CFR Part 820 and ISO 13485
- Development of Quality Manuals and SOPs
- Audits and assessments of existing QMS
Compliance Audits and Inspections
- Conducting internal audits to ensure compliance with regulatory standards
- Preparing for and managing FDA inspections and audits
- Identification and resolution of compliance issues
Clinical Trials and Studies
- Design and management of clinical trials and studies
- Preparation of clinical trial applications and documentation
- Compliance with Good Clinical Practice (GCP) guidelines
Risk Management
- Development and implementation of risk management plans
- Conducting risk assessments and Failure Mode Effects Analysis (FMEA)
- Ensuring compliance with ISO 14971 for risk management
Post-Market Surveillance
- Monitoring and reporting of adverse events and device performance
- Implementation of post-market surveillance and vigilance processes
- Management of corrective and preventive actions (CAPA)
Training and Education
- Training programs on regulatory requirements and compliance
- Workshops and seminars for staff on medical device regulations
- Customized training based on specific regulatory needs
Regulatory Updates and Alerts
- Providing updates on changes in medical device regulations
- Alerts about new compliance requirements or industry standards
- Guidance on integrating regulatory changes into existing practices
Regulatory Consulting
- Expert advice on navigating complex regulatory landscapes
- Assistance with regulatory strategy and compliance challenges
- Tailored solutions for specific device types and markets
Labeling and Advertising
- Compliance review of labeling and promotional materials
- Assistance with ensuring labeling meets FDA and international standards
- Development of compliant advertising strategies