Medical Device & IVD CRO for PMCF and Clinical Studies
RegHelps SRC is a contract research organisation (CRO) for medical device and in vitro diagnostic (IVD) manufacturers. We design and manage clinical investigations, performance evaluations, post-market clinical follow-up (PMCF) and post-market performance follow-up (PMPF) studies in line with EU, UK, US and India regulations.
As the central coordinator for multi-site, multi-expert research, we connect manufacturers, clinical sites, laboratories and regulatory specialists from study design to final report.
Reviewed by Nagachandra Bhardwaj, Co-Founder & CTO · Last updated
We provide time-bound, cost-effective PMCF plans and reports in line with Article 61(11), Annex XIV, and MDCG guidance.
What is PMCF and how do we support it under EU MDR?
The RegHelps PMCF strategy combines proactive data collection, continuous clinical evidence generation, and expert regulatory alignment to help manufacturers comply with local and international regulatory requirements.
- PMCF Plan & Protocol
- Site, Investigator & Patient Recruitment
- Data Analysis & Reporting
- Risk Mitigation & Compliance
Deliver efficient, compliant, and cost-effective clinical investigations managing every step from planning to reporting, to generate high-quality evidence that meets global regulatory requirements.
How do we run ISO 14155 clinical investigations?
RegHelps conducts ISO 14155-compliant clinical investigations, from first-in-human (FIH) to pivotal trials, managing data, safety reporting, and analysis to deliver strong evidence for CE Marking, FDA Approval, or CDSCO licensing.
- Feasibility & Strategy, Ethics Submissions
- Site & Investigator Management
- Subject Recruitment & Consent
- Monitoring, Data, Safety, Biostatistics & Reporting
RegHelps helps manufacturers meet Human Factors and Usability requirements covering IEC 62366-1 studies, analysing user risks, and delivering complete HFE reports for safe, effective, and intuitive devices.
How do we meet human factors and usability (IEC 62366-1) requirements?
Integrate human factors engineering into every stage of device development, identifying critical user interactions, mitigating use-related risks, and conducting IEC 62366-1/FDA compliant usability testing to ensure regulatory readiness and optimise device safety and usability.
- Identify tasks, use errors & mitigate risks
- Plan & manage usability testing (IEC 62366-1, FDA)
- Prepare HFE reports for submissions
- Align findings with ISO 14971 & documentation
RegHelps prepares IVDR 2017/746 compliant Performance Evaluation Reports covering scientific validity, analytical, and clinical performance, together with post-market performance follow-up (PMPF) plans and reports, to support CE marking and withstand Notified Body review.
How do we prepare IVD performance evaluations and PMPF under IVDR?
Our strategy is to deliver thorough, evidence-based PERs that integrate scientific validity, analytical accuracy, and clinical relevance, ensuring compliance with IVDR, strengthening technical documentation, and enabling smooth Notified Body approval.
- Scientific Validity – Evidence of clinical relevance
- Analytical Performance – Accuracy and reliability data
- Clinical Performance – Results aligned with clinical condition
We handle the entire process from gap assessment to final approval, ensuring zero missed compliance points
Which certifications do we support: CE marking, UKCA and FDA 510(k)?
Tailored strategies for each client’s product type, risk classification, and target markets. We identify and address potential red flags early, preventing costly rejections or rework. Our in-house team of industry veterans has hands-on experience in medical device, IVD, and software submissions, ensuring accuracy and faster approval timelines.
- MDR CE Marking – TechFile, NB Coordination, EU Representation
- IVDR CE Marking – TechFile, NB Coordination, EU Representation
- UKCA Marking – TechFile, UK Approved Body Coordination, UKRP Representation
- FDA 510(k) – TechFile, FDA Coordination, US Agent Service
- GMP/ISO 13485/QMSR/MDSAP Services
- Biological Evaluation and ISO 14971 Risk Management
Our Customers
We support medical device and IVD manufacturers, from start-ups preparing their first clinical study to established companies maintaining CE marking and FDA clearance across the EU, UK, US and India.
