Our scientists and engineers help clients design and implement practical systems to meet FDA, ISO, EU MDR, EU IVDR and MDCG quality standards, regulations, 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