Best Medical Device CRO in India
Bioexcel is a global Contract Research Organization supporting medical device and IVD manufacturers in MDR and IVDR transition with customized, cost-effective solutions.
Why Partner with a Specialized CRO for Medical Devices & Diagnostics?
A Medical Device CRO or IVD CRO is a specialized Contract Research Organization that supports the medical device and diagnostics industry by providing outsourced research, clinical, and regulatory services. These services range from biological assay development, clinical development, clinical trial management, regulatory submissions, to real-world evidence generation.
By partnering with a CRO, manufacturers and innovators can reduce costs, save time, and simplify market entry. Instead of building large in-house teams, MedTech companies can rely on CROs like Bioexcel to accelerate device development while ensuring compliance with global regulations such as EU MDR, IVDR, FDA, UKCA, CDSCO (India) and more.
While many CROs provide general support, Bioexcel stands out by offering focused expertise in medical devices and diagnostics only. We believe that success in one therapeutic area should not be assumed to translate across all fields. That’s why at Bioexcel, we work within our domain of strength—medical devices and IVDs—where our expertise is proven and trusted by manufacturers worldwide.
Bioexcel’s Role & Regulatory Foundations
The International Council on Harmonisation (ICH) defines a Contract Research Organization (CRO) as “a person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.”
At Bioexcel, we embrace this definition with a dedicated focus on medical devices and in-vitro diagnostics (IVDs). While sponsors may delegate certain clinical and regulatory activities, the ultimate accountability for trial quality and data integrity always remains with the sponsor. Bioexcel provides the expertise, systems, and compliance framework to ensure success at every stage.
Bioexcel Advantage – Backed by Global Regulatory Expectations
Aligned with Global Standards
Bioexcel ensures every study complies with ICH GCP, ISO 14155:2020, MDR/IVDR, and FDA standards
Shared Responsibility with Sponsors
Sponsors stay accountable, while Bioexcel ensures oversight, data integrity, and compliance.
Risk-Based Monitoring Expertise
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Reliable Outsourcing Partner
Sponsors trust Bioexcel for precise trial, writing, and regulatory support.
Data Integrity & Patient Safety First
Bioexcel prioritizes ethics, data accuracy, and patient safety.
Agility with Compliance
Bioexcel delivers fast, cost-effective, flexible, and globally compliant CRO solutions.
Governance Strategy & Operating Model
At Bioexcel, we believe successful partnerships are built on trust, transparency, and shared objectives. Our governance model is designed to align sponsor and CRO goals, ensuring that projects run smoothly with clarity in roles, responsibilities, and outcomes. By integrating resources, processes, technology, and metrics, we create a strong foundation for strategic outsourcing that benefits all parties.
We go beyond traditional models—working with sponsors to challenge outdated practices and adopt smarter approaches that improve efficiency, reduce costs, and accelerate compliance.
CRO Culture at Bioexcel
Our culture is defined by honesty, integrity, and ethical conduct. Every decision we make is guided by our responsibility to patients, sponsors, and regulators. At Bioexcel, we believe doing the right thing is not optional—it’s who we are.
Integrity in Action
Our team is committed to fairness, transparency, and accountability, even in challenging situations
