What we do

Our scientists and engineers work with yours to design and implement practical systems to meet FDA, ISO, and IMDRF quality standards, regulatory requirements, and guidelines.

Systems

We develop customized, linked, easy-to-use systems including:

  • Quality Systems compliant with current requirements of FDA, ISO 13485, Health Canada, etc.
    • Quality System Manual
    • Quality System Procedures
  • Design Control & Documentation
    Customized systems to meet the most stringent QA standards, linked to project management
  • Quality Assurance
    Multi-tier systems that incorporate FDA (cGMP/GLP/GTP/GCP), ISO and IMDRF regulations and guidelines that are continually updated to new requirements. Call us for recommendations on how to obtain the certification you need.
  • Regulatory Affairs
    Detailed regulatory assessments, Clinical and Design Verification study design, data analysis, and report writing. Writing and support of all types of submissions to global regulatory agencies.

Planning & Reporting

We develop plans, write protocols, provide support, analyze data, and prepare reports for:

  • Project Management
    Detailed task lists for all phases applicable to your product, integrated with document control and design control
  • Clinical Trials
    We can handle segments from developing a plan, writing the protocol, analyzing the data, to preparing the reports
  • Research and clinical manuscripts
    • Scientific and clinical literature review reports for support of EU requirements
    • Review of data and writing of scientific articles for publication
  • Manufacturing/Technical Support
    Process design, verification and validation; requirement specs, oversight of line design and equipment IQ/OQ/PQ
  • Product Development
    Optimize product development, establish technical performance, write reports to support labeling claims
  • International Services
    Comprehensive strategies for working with regulatory agencies, component suppliers and OEM manufacturers

Supplemental Services

Rounding out our end-to-end services approach, we also provide:

  • System Audits
    Due diligence for potential investors; independent audits to assess existing systems; pre-ISO compliance audits; written reports of findings, suggestions for improvements; personnel training
  • Candidate Evaluation
    We can assist you interviewing candidates for key scientific and regulatory positions
  • Personnel Training
    Training of scientific staff; company-wide quality systems training