If you are seeking to receive high-quality professional services this is your ultimate destination! Whether your project is large or small, our team of experts can provide the resources and solutions you need to get the job done right. Our track record for consistency, timely service, and subject matter expertise make insurmountable tasks possible to overcome.
We provide the full support to your commercial product, starting with logistisc, internet marketing, device design and regulatory compliance consultations to make sure your product is competitive on the international market.
Our multifaceted company has extensive experience in all aspects of the regulatory processes of 510(k), 513(g), Pre-IDE, IDEs and PMA/BLA submissions. Our successes with 510(k)s, PMA, and IDEs, are summarized in our 510/IDE/PMA.
Design and packaging developement
ISO conformity consultations
510(k) Submission (Pre-Market Notification)
513g Submissions for Classification Ruling
IDE (Investigational Device Exemption)
PMA/BLA (Pre-Market Approval)
Human Factor Study and Performance Testing
Cosmetic GMP and 9001 GMP Gap Analysis
Quality System Compliance
Quality System Part 820 (cGMP) Templates for small and large companies
Quality System Implementation
Quality System Audits
Warning Letter Response