Five Essential Questions to Ask Before Choosing a Preclinical CRO for Your Medical Device

Selecting the right preclinical CRO (Contract Research Organization) can make or break your medical device’s path to commercialization. Whether you are preparing for FDA preclinical testing, a 510(k) submission, or IDE application, the right partner ensures regulatory compliance, scientific integrity, and efficient execution. 

At BioBoston Consulting, we guide medtech innovators through this critical decision-making process. Below are five must-ask questions every medical device company should consider when evaluating a preclinical CRO. 

 

1. Are You GLP Compliant and Well-Versed in Regulatory Requirements?

Before selecting a CRO, confirm their compliance with Good Laboratory Practice (GLP) as outlined in 21 CFR Part 58. This is essential for the integrity of your data and the success of your submission to the FDA, EMA, or Notified Bodies for CE Marking. 

A qualified preclinical CRO should have: 

• A strong GLP-compliant quality system 

• Established Standard Operating Procedures (SOPs) 

• Independent Quality Assurance (QA) oversight 

• Deep understanding of regulatory pathways like 510(k), IDE, De Novo, CE Mark, and pre-submissions 

 

2. Are You AAALAC (The Association for Assessment and Accreditation of Laboratory Animal Care) Accredited and Do You Have a Clean USDA/FDA Inspection Record?

When working with animal models in preclinical studies, a CRO’s animal welfare standards are non-negotiable. Look for AAALAC accreditation, which ensures adherence to the highest standards in animal care and use. Also, inquire about their inspection history with the USDA and FDA. 

A preclinical CRO should: 

• Be AAALAC-accredited 

• Have no major citations from USDA or FDA inspections 

• Maintain SOP-driven animal welfare programs 

• Employ skilled veterinarians and support staff for all phases—anesthesia, surgery, and post-op care 

 

3. Can You Deliver Fast Yet Reliable Timelines?

In medical device development, everyday counts. Delays in preclinical testing can lead to significant cost overruns. Ask prospective CROs about their average turnaround times for protocol approval, study initiation, and final report generation. 

What to look for: 

• Realistic yet expeditious timelines 

• Transparent communication on progress 

• Quick turnaround for data reporting and regulatory responses 

• Responsiveness to client needs and adaptability to tight deadlines 

 

4. Do You Understand the Science Behind My Device?

Your CRO should be more than just a service provider—it should be a strategic scientific partner. They should understand your device’s mechanism of action, intended clinical use, and surgical or technical nuances. 

A technically fluent preclinical CRO will: 

• Speak the language of your engineers, scientists, and clinicians 

• Execute procedures that mirror real-world clinical applications 

• Translate device intent into practical study execution 

• Help optimize study design for regulatory success 

 

5. Do You Have the Resources (and Network) to Support Study Complexity?

From imaging modalities and histopathology to surgical talent and contingency protocols, your CRO must demonstrate capability, scalability, and resource readiness. 

Key follow-up questions include: 

• What imaging and lab capabilities are available in-house? 

• Do you perform histology and pathology internally? 

• Can you introduce clinical specialists or surgeons as needed? 

• How have you managed past operational failures, if any? 

 

Final Thoughts: Make the Right CRO Choice with Confidence 

Choosing the right preclinical CRO for your medical device can accelerate your regulatory submissions, minimize costly delays, and strengthen the credibility of your data package. With BioBoston Consulting as your strategic regulatory and development partner, we ensure you are equipped to make informed decisions and connect with CROs that align with your technical and regulatory goals. 

 

🚀 Need Expert Guidance on CRO Selection or Preclinical Readiness? 

BioBoston Consulting specializes in helping medical device companies navigate preclinical strategy, CRO selection, and regulatory planning. Whether you are preparing for FDA IDE submission, EU MDR/IVDR preclinical testing, or seeking GLP-compliant CROs, our team offers personalized, science-backed guidance to accelerate your path to market. 

👉 Connect with BioBoston Consulting today for a tailored consultation. Let us help you identify the right CRO and ensure your device is ready for successful preclinical testing and regulatory approval.