1. Regulatory Strategy Development: We work closely with you to develop a tailored regulatory strategy that aligns with your products goals and market objectives. Our experts provide guidance on navigating FDA regulations, international standards, and quality management systems.

2. Preparation of Regulatory Submissions: Our team assists in preparing and submitting regulatory documentation, including PMA, and 510(k) premarket notifications, CE mark applications, and other regulatory filings. We ensure that all documentation is accurate, complete, and compliant with regulatory requirements.

3. Regulatory Compliance Audits: We conduct comprehensive audits of your quality management systems and manufacturing processes to identify any gaps or areas of non-compliance. Our goal is to help you proactively address issues and maintain regulatory compliance.

4. Labeling and Packaging Compliance: We provide labeling and packaging to ensure that your medical laser products meet all regulatory standards for safety, efficacy, and proper use, and communicate the associated risks to the end users.

5. Post Market Surveillance: Our support doesn’t end once your product is on the market. We participate in post-market surveillance systems to monitor the safety and performance of your medical device and ensure compliance with regulatory reporting requirements.

6. New FDA Regulations: We are ready for the new FDA requirements for incorporation by reference of ISO-13485.