full range of services for your business

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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

Compliance and Enforcement Assistance

FDA 483 and warning letter responses, recalls, corrections, understanding enforcement issues, and provide in-house training 

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)

Regulatory Project Management & Information Technology


Distribution

Distributor selection, due diligence, audit

Product Development

Design control,risk management/assessment, hazard analysis, IEC 60601-1 Medical Device Safety, software quality assurance (SQA), software development