SERVICES OFFERED

Quality Assurance and Compliance

¨       Audits  (GMP/QSR, GxP, ISO, etc)   (US & International)

¨       MDR, Traceability

¨   Response and Resolution

        ¨   Part 806

        ¨   Recall 

      ¨     FDA Warning Letter

¨   QSIT, HACCP

¨   Risk Management

¨   Hazard Analysis

¨   Root Cause Analysis

¨   Quality Systems Development

¨   Quality System Audits

¨       ISO 9001:2000,  EN/ISO 13485,  MDD93/42/EEC Annex II

¨       Design Control Audits

¨       Validations

¨       CE-Mark

¨       Packaging, Sterilization

¨       GMP/QSR Development

¨       Software Testing

¨   Other Compliance Issues

Strategic Regulatory Consulting & Submissions

¨       510(k) and IDE / PMA submissions, amendments and supplements

¨       Laser Product Radiation Reports

¨       Establishment Registrations. Device Listing, US Agent.

¨       Negotiations with Government Agencies

¨       International Dossiers

¨       US & International Strategic Regulatory Planning

¨       FDA-483, Warning Letter Replies,

¨       Injunction Strategies

¨       Other Regulatory Consulting

Management Consulting

¨       Training; Management/Staff Orientation

¨       Process Improvement

¨       Protocol Development

¨       Procedure Manual Development

¨       Document Review

¨       Strategic Planning

Validation Consulting

¨       Development of Master Plans

¨       Protocol Development

¨       Process Validations

¨       Software  (IQ, OQ, PQ)

    ¨       Software Requirements Specifications

    ¨       Software Test Planning and Protocols

    ¨       System Testing 

    ¨       SOP development

    ¨       Training

    ¨       Validation Report Package