The Best Medical Device & Diagnostics CRO
Navigate the complexities of clinical research with confidence. Our expert guide helps you select the right Clinical Research Organization for your PMCF studies and clinical trials.
ISO Certified
ISO14155, ISO9001, ISO13485 compliance
Expert Team
Ex-leaders from competent authorities
Quality First
Regulatory compliance guaranteed
Global Reach
Worldwide partnerships & capabilities
Why Outsource to a CRO?
Over the past decade, medical device and diagnostic companies have increasingly turned to Clinical Research Organizations for product development services. This strategic move enables device companies to leverage specialized infrastructure, navigate complex regulations, and focus on their core competencies of developing innovative devices and diagnostics.
Key Considerations for Selecting a CRO
What should a medical device & diagnostic sponsor consider when choosing the right clinical research partner?
Quality Standards
Quality of work is directly linked to compliance with regulations. Ensure the CRO holds relevant quality standard documents:
- ISO14155 – European Clinical Investigation
- ISO9001 – Quality Management Systems
- ISO13485 – Medical Device Quality
Bioexcel maintains all critical certifications with regular audits
Trial Capabilities
Global reach and full-service solutions..... Does the CRO have the capabilities and partnerships needed for your study regions?
- Global partnerships and site networks
- Full-service capabilities (CTMS, eCRF, etc.)
- Therapeutic area expertise
- Product type specialization
Studies often involve multiple vendors – full-service saves time
Cost Transparency
Cost is a key factor, but comparison must be fair and comprehensive:
- Compare unit costs and line items, not just totals
- Transparent pass-through cost disclosure
- All study specifications included upfront
- No hidden future cost increases
⚠️ Very low costs may indicate missing specifications
Global vs. Specialized CROs
Are global big medical device CROs always the solution? Understanding the differences matters.
Global CROs
Large organizations with famous names
Potential Challenges:
- Pharma-focused, may lack medical device nuances
- High project manager churn rates
- Shared resources across multiple projects
- Compartmentalized operations lose holistic view
- Extra organizational layers increase fixed costs
“SMEs often approach big companies feeling it’s safer, but experience disappointment with staff turnover and lost context”
Specialized CROs
Specialized medical device experts
Key Advantages:
- 100% dedicated to medical device & diagnostic trials
- Stable expert teams with minimal churn
- Lean approach improves cost efficiency
- Quick access to operations and executive teams
- Personal, highly responsive service
“Bioexcel offers boutique CRO advantages with global capabilities and expert teams from competent authorities”
In Vitro Diagnostic (IVD) Considerations
Specialized expertise for diagnostic companies
The process for selecting an IVD CRO is similar to medical device CRO selection, but there are important nuances worth considering:
Dedicated IVD Regulatory Experts
Essential for navigating IVDR pathways and ensuring compliance with diagnostic-specific regulations
IVD Operations Experience
Project managers and CRAs with direct IVD trial experience understand unique requirements
Tailored Approach
Customized strategies for diagnostic validation studies and performance evaluations
Bioexcel has dedicated IVD experts who provide a tailored approach to diagnostic trials, ensuring quality and addressing these considerations effectively.
Making Your Selection Decision
Quality & Experience
Proven track record with certifications
CRO Capabilities
Full-service solutions and partnerships
Team Stability
Low churn of project managers
Cost Efficiency
Transparent pricing without surprises
Ready to Select Your CRO Partner?
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Your CRO Partner
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