Medical Device & IVD CRO For Clinical, Regulatory & Digital Compliance
End-to-end support across the Medical Device & IVD lifecycle — from Clinical Investigation and Clinical Evaluation to Global Regulatory Approval and Post-Market Compliance.
- EU MDR & IVDR Clinical Evidence Experts
- CER,PER,PMCF & Global Regulatory Submissions
- Platform Enabled Materiovigilance & Clinical Trial Automations
What We Do?
Specialized exclusively in Medical Devices & In Vitro Diagnostics (IVDs).
Clinical & CRO Services
- EU MDR Clinical Investigations
- CER & Literature Evaluation
- IVDR Performance Evaluation
- PMCF & Post-Market Studies
- Real-World Evidence
Regulatory Affairs
Structured regulatory strategy and technical documentation for EU MDR, IVDR, FDA, CDSCO, and global submissions aligned with Notified Body expectations.
Digital Compliance Platforms
Audit-ready automation for clinical trials, PMS, PSUR, signal detection, and global vigilance reporting through Vigi X™ and Xceltrials™.
Services We Offer
Clinical & CRO Services
End-to-end clinical evidence generation including EU MDR Clinical Investigations (ISO 14155), Clinical Evaluation Reports (CER), IVDR Performance Evaluation Reports (PER), PMCF strategy, and global regulatory alignment to support market approval and post-market compliance.
- EU MDR Clinical Investigations (ISO 14155)
- CER & IVDR PER Preparation
- PMCF & Real-World Evidence Studies
As a specialized Medical Device CRO, we support manufacturers from clinical investigation through post-market compliance.
Regulatory Affairs Services
Strategic regulatory planning, technical documentation preparation, and global submission management under EU MDR, IVDR, US FDA (510(k)/De Novo), CDSCO, and UKCA frameworks.
- EU MDR & IVDR Technical Documentation
- FDA 510(k), De Novo & Global Submissions
- Device Classification, Licensing & Post-Approval Support
Supporting Class I, IIa, IIb & III medical devices and IVDs.
Technical & Quality Services
Regulatory aligned technical documentation, risk management (ISO 14971), GSPR mapping, biological evaluation, and quality system documentation support to meet EU MDR, IVDR, and global medical device requirements.
- GSPR & Annex II/III Technical Documentation
- Risk Management Files (ISO 14971)
- Biological Evaluation & Technical File Gap Assessment
Digital Compliance Platform
Technology enabled compliance platforms designed for audit-ready clinical and post-market management. Vigi X™ streamlines PMS, vigilance reporting, and signal detection under EU MDR & global regulations, while Xceltrials™ enables structured clinical investigation and evidence management.
- PMS & Vigilance Automation (MDR/IVDR aligned)
- Clinical Trial Documentation & Evidence Tracking
- Audit-Ready Regulatory Reporting
Replacing manual spreadsheets with structured, regulator-ready digital workflows.
Our Applications Cover Diverse Corporate Markets
Clinical, Regulatory & Digital Compliance Partner for Medical Devices & IVD Companies
EU MDR & IVDR-focused clinical investigations, CER/PER development, global regulatory submissions, and platform-enabled post-market compliance.
100+ Projects | 20+ Countries | Specialized Medical Device CRO
Medical Device Segments We Support
Supporting complex Class I, IIa, IIb & III medical devices and IVDs across global regulatory pathways.
Cardiology
Cardiac implants, coronary and peripheral stents, structural heart devices, electrophysiology systems, heart rhythm management devices, and cardiovascular diagnostic technologies.
Orthopedics
Joint replacement systems, trauma fixation devices, spinal implants, sports medicine technologies, bone graft substitutes, and rehabilitation devices.
Neurology
Neurostimulation systems, stroke intervention devices, brain monitoring technologies, epilepsy management devices, and Parkinson’s disease therapeutic systems.
Oncology
Tumor biopsy systems, radiation therapy equipment, interventional oncology devices, minimally invasive surgical oncology tools, and cancer diagnostic IVD platforms.
Ophthalmology
Intraocular lenses (IOL), retinal imaging systems, glaucoma management devices, ophthalmic surgical technologies, OCT systems, and vision correction devices.
Respiratory Care
Ventilators, CPAP/BiPAP systems, inhalation drug-delivery devices, nebulizers, pulmonary monitoring devices, and sleep apnea management technologies.
In Vitro Diagnostics
Ventilators, CPAP/BiPAP systems, inhalation drug-delivery devices, nebulizers, pulmonary monitoring devices, and sleep apnea management technologies.
General & Minimally Invasive Surgery
Laparoscopic systems, electrosurgical devices, endoscopic instruments, surgical navigation systems, and sterile disposable surgical technologies.
Endovascular & Interventional Devices Care
Catheters, guidewires, balloon dilatation systems, vascular closure devices, thrombectomy systems, and peripheral intervention technologies.
Trusted by Global Medical Device & IVD Manufacturers
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