full range of services for your business

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Product Development

Consultation services for design control,

risk management/risk assessment/hazard analysis, and IEC 60601-1 Medical Device Safety, software quality assurance, and software development 

Submissions for Pre Market Approval

Support with 510K, PMA, & technical dossier creation & submission, FDA or Notified Body interaction, 510K Refuse to Accept (RTF) & E-copy assistance, and FDA requests for additional information (AI or RAI)

Compliance and Enforcement Assistance

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

Local Agent Representation

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

Regulatory Project Management & Information Technology