Bringing your product to the market in multiple countries can be a rewarding but often daunting task. Let our experience with regulatory agencies, component suppliers, and OEM manufacturers smooth the way for you.
We can help with:
- Regulatory assessments for agency requirements
- Documents to support product claims
- Writing and support of regulatory filings
- EU Literature Reviews / Clinical Evaluation Reports
- Product labeling and packaging requirements
- Technical Support information
- OEM and vendor audits
- Compliance assessment of existing systems