full range of services for your business

Submissions for Pre Market Approval

510K, PMA, technical dossier, all submissions for FDA or Notified Body, 510K Refuse to Accept (RTF), E-copy assistance, and FDA requests for additional information (AI or RAI) - click for more information

Quality Management Systems

Quality System implementation, audit support and gap analysis (MDSAP, QSR/GMP-21 CFR Part 820, ISO 13485, ISO 9001, etc.)

Digital Health and Cybersecurity Consulting

Meet regulator expectations and reduce your risk of cyber threats with early cybersecurity assessments.

Local Agent Representation

In-country agent services (prepare required documents, track alerts, assist with FDA inspections, communicate with the local agency, and ensure appropriate conformity)

Distribution

Distributor selection, due diligence, audit

Registered FDA Agent

Assist in communications with FDA, monitor your facility's FDA compliance assist in scheduling FDA inspections, provide guidance with FDA requirements

Patient Advocacy

Breaking down barriers to the quality healthcare patients deserve. Especially those diagnosed with chronic, life threatening or debilitating health issues to help ensure access to the best care possible, maximizing their insurance benefits as a nonprofit healthcare industry leader. We offer bilingual free or minimal cost support, education and guidance to patients nationwide.