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.
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
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