Device Filing to FDA Service
Compliance Insight and their expertise in Medical Device FDA Regulations has been helping the medical device industry improve global health for more than two decades.
Whether you are developing a brand new product or are refreshing an existing device, our Medical Device FDA Regulation experts will guide you through each phase of the review process. We’ll leverage our decades of industry experience to facilitate FDA regulatory approval so you can bring your product to market, and ultimately: make a difference in patient care.
Select Services & Capabilities
- Strategic Planning
- Product Classification
- Medical Device Reporting
- Agency Relations
- CMC Compliance
- FDA Submissions
- Monitor Submissions and Approvals
- 510(k) Research
- Technical Comparisons
- Document Preparation
- Review Testing Requirements
- Review Applicable FDA Guidelines & Standards
- Quality Compliance
- Prepare & File Class Applications
- Quality System Audit
- Label & Advertising Review
- Regulatory Issues
- Risk Management
- 510(k) Submission
- cGMP compliance
Group Purchasing Service
We strive to strengthen customers’ delivery of high-value care by aligning cost, quality, and market performance. Just like GPO for health and medical field, we offer group purchasing service to small businesses and Amazon Sellers. Our suppliers play a critical role in helping us fulfill this commitment. In turn, we deliver the commitment, visibility and credibility suppliers need to enhance connection points and growth opportunities with customers.
Dropship
Dropship is the model without a middleman that offers the opportunity for retailers to hugely benefit by selling products directly from the manufacturers or distributors to the customers. Amazon sellers or retailers simply place orders on the our website. We will ship the products directly to the customers. With the dropship service, your profit is the difference between your selling price and the price of the items we offer to you.
The delivery will under your name, with the style you like.
