Global Medical Device CRO & Regulatory Partner
About Us
Bioexcel supports medical device and IVD manufacturers with structured clinical evidence, regulatory strategy, and digital compliance solutions under MDR, IVDR, FDA, and global frameworks.
About Us
Real-life strategy to reach your goals.
Bioexcel is a specialized clinical, regulatory, and digital compliance partner dedicated exclusively to medical device and IVD manufacturers.
We support companies across the full product lifecycle from structured clinical evidence generation and regulatory submissions to post-market surveillance and compliance automation.
Our strength lies in combining regulatory expertise, scientific rigor, and purpose-built digital platforms to meet evolving Notified Body and global regulatory expectations.
We work under EU MDR, IVDR, US FDA, CDSCO, and international regulatory frameworks.
WHO WE ARE
Real-life strategy to reach your goals.
Bioexcel is a specialized medical device and IVD clinical and regulatory organization built to support complex global market access pathways.
Our team brings together clinical researchers, regulatory strategists, biostatisticians, and quality experts with hands-on experience across EU MDR, IVDR, US FDA, CDSCO, and international frameworks.
We focus exclusively on medical technologies enabling manufacturers to navigate evolving regulatory landscapes with structured, audit-ready, and risk-based approaches.
WHY CHOOSE BIOEXCEL
We strive for diversity across the globe
- MDR & IVDR-Focused Expertise: Deep hands-on experience in EU MDR, IVDR, US FDA, CDSCO, and global regulatory pathways.
- Clinical Evidence-Driven Strategy : Structured clinical evaluation, PMCF planning, and performance evaluation aligned with notified body expectations.
- End-to-End Lifecycle Support : From concept and regulatory strategy to post-market surveillance and digital vigilance automation.
- Audit-Ready Documentation : Technical files, CER, PER, Risk Management, PMS & PSUR built for regulatory scrutiny.
Leadership Team
Our Leader
Bioexcel is led by professionals with hands-on experience across clinical operations, regulatory strategy, and business development for medical devices and IVDs. Our leadership ensures every project is audit-ready, regulator-aligned, and execution-focused from evidence planning to post-market compliance.Our Leader
“Bioexcel is led by professionals with hands-on experience across clinical operations, regulatory strategy, and business development for medical devices and IVDs. Our leadership ensures every project is audit-ready, regulator-aligned, and execution-focused from evidence planning to post-market compliance.”
Amandeep Kaur
Director – Clinical OperationsAmandeep Kaur
“Amandeep leads Bioexcel’s clinical operations and delivery. She supports medical device and IVD manufacturers with clinical investigation execution, CER/PER support, PMCF/PMS planning, and real-world evidence programs—ensuring structured documentation and compliance with EU MDR/IVDR and ISO 14155 expectations.”
- Clinical Investigation Support (ISO 14155)
- CER / PER / PMCF / PMS execution
- Multi-center coordination & site readiness
- Documentation quality & audit readiness
Jaspal Singh
Director – Business DevelopmentJaspal Singh
“Jaspal leads business development and strategic partnerships at Bioexcel. He works closely with medical device and IVD manufacturers to understand their regulatory and evidence needs and aligns Bioexcel’s clinical, regulatory, and digital compliance offerings (VigiX™ & XcelTrials™) to support faster, smoother market access and lifecycle compliance.”
- Client partnerships & solution mapping
- Regulatory + evidence roadmap discussions
- Product-market fit for VigiX™ & XcelTrials™
- Long-term account strategy & growth
