Research Collective Handling CRO
We serves as the central coordinator for multi-site, multi-expert research initiatives, ensuring seamless collaboration between manufacturers, clinical sites, laboratories, and regulatory specialists. RegHelps scope of work covers the full research and regulatory cycle from designing and managing clinical investigations and performance evaluations, to overseeing post-market clinical follow-up (PMCF) and post-market performance follow-up (PMPF) activities for Medical and Invitro Diagnostic devices in compliance with EU, UK, US and India Regulations
We provide time-bound, cost-effective PMCF plans and reports in line with Article 61(11), Annex XIV, and MDCG guidance.
Post Market Clinical Follow Up (PMCF)
RegHelps PMCF strategy combines proactive data collection, continuous clinical evidence generation, and expert regulatory alignment to help manufacturers comply local and international regulatory requirments
- 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.
Clinical Investigation and Clinical Trials
RegHelps conduct ISO 14155 compliant clinical investigations from 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
Human Factors and Usability
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 to support CE marking and withstand Notified Body review.
IVD Performance Evaluation (PER)
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
Product and System Certification Service
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. Industry veterans and in-house team with 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, CB Coordination, UKRP Representation
- FDA 510K – TechFile, FDA Coordination, US Agent Service
- GMP/ISO/QMSR/MDSAP Services
Our Customers
From innovative start-ups to global leaders, our customers inspire us every day. Their trust drives our commitment to deliver unmatched regulatory solutions with precision and care. We are honoured to support visionary companies shaping the future of healthcare. Every logo here represents a story of collaboration, trust, and shared achievement.Our customers are at the heart of everything we do. Together, we turn complex regulatory challenges into success stories recognised worldwide.
