A Unique Approach
We'll act as a commercially-minded extension of your team, taking lead on your project to get through the complex and ever-changing quality and regulatory requirements to be on market.
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Regulatory
Affairs
- Regulatory strategy & guidance
- Pre-submission and FDA meeting support
- 510(k), de novo, PMA FDA submission
- CE-mark (MDD/MDR, IVDD/IVDR)
- Health Canada license
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CRO
Services- Study Design and Protocol Development
- Site selection, contracting and IRB
- Study management, monitoring, auditing
- EDC development and testing
- Data management, monitoring and auditing
- BIMO audit support
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Quality
Systems Compliance- QMS development, implementation and training
- Gap Audits (US FDA QSR, ISO 13485:2016, MDSAP, ISO 9001:2015)
- Certification support and audit management for ISO, MDSAP, IVDD/IVDR and MDD/MDR
- Internal Quality Audits (IQA)
- CAPA audit and implementation
- FDA inspection and warning letter support
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Point-of-Care Analyzer Remote Training
- CLIA waiver and Moderately Complex Analyzers and Tests
- Training program and material development
- Life video remote user training
- Performance Verification: protocol development, data entry & analysis, PV reports
- Software and product updates training
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Market Research / Marketing Support
- Market research reports
- Advisor Boards
- Voice-of-Customer surveys and phone interviews
- Thought-leader introductions
- Product launch and Go-to-Market strategies
- Facility and contact lists
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Applications / Product Areas
Applications
- Microbiology
- Infectious Diseases
- Clinical chemistry
- Endocrinology
- Diabetes
- Women’s health
- Hematology
- Oncology
Product Types
- Point-of-Care Test
- Molecular Diagnostics
- Single-plex PCR
- Syndromic panels
- Antimicrobial susceptibility testing
- Culture media
- Mass spec/MALDI
- Immunohistochemistry
- Microarrays
- FIT assays
