OPERON ELEVATEPLUS | CLINICAL SERVICES FOR MEDICAL DEVICES
Clinical Services for Medical Devices & IVDs Across Global Regulatory Markets
Navigating medical device clinical research and regulatory pathways requires rigorous adherence to global standards. Operon Strategist operates as a leading medical device Clinical Service provider that medical device manufacturers rely on, offering end-to-end clinical study management and regulatory support for every medical device clinical investigation. Whether you are a medical device startup exploring clinical and regulatory pathways or an established global manufacturer, we manage your complete clinical lifecycle—from initial evidence planning and protocol drafting to approvals, ISO 14155 execution, and Post-Market Clinical Follow-up (PMCF).
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Operon ElevatePlus Clinical Service Portfolio
Our comprehensive service portfolio spans four core clinical pillars designed to support the clinical investigation of medical devices and deliver robust evidence across global markets:
Conducted before and during early product development
Covers clinical and regulatory feasibility assessment
Evaluates requirements across one or several target markets
Identifies applicable clinical evidence requirements and regulatory pathways
Assessment of applicable global regulatory frameworks, clinical evidence requirements, and market-specific approval pathways
Medical Devices Rules 2017: clinical investigation permission, ethics committee, CTRI
EU MDR 2017/745, ISO 14155, MDCG guidance
21 CFR 812 (IDE), 21 CFR 50 and 56, clinical data for 510(k), De Novo, PMA
MDS – G20, MDS – REQ 2 and other international regulatory guidance.
Initial and lifecycle assessment of clinical data
Safety, performance, and benefit-risk conclusions
Supports technical files, Notified Body, and authority submissions
Includes post-market clinical follow-up (PMCF)
Medical Devices Rules 2017: clinical investigation permission, ethics committee, CTRI
EU MDR 2017/745, ISO 14155, MDCG guidance
21 CFR 812 (IDE), 21 CFR 50 and 56, clinical data for 510(k), De Novo, PMA
MDS – G20, MDS – REQ 2 and other international regulatory guidance.
Early-stage pilot, pivotal confirmatory, and post-market clinical studies
Single-country and multi-center, multi-country clinical trial programs
Standalone medical devices and drug-device combination products
Delegated sponsor duties, registry registrations, and oversight committee management
End-to-end execution from study planning to final report, fully aligned with ISO 14155, EU MDR, and local market rules
Medical Devices Rules 2017: clinical investigation permission, ethics committee, CTRI
EU MDR 2017/745, ISO 14155, MDCG guidance
21 CFR 812 (IDE), 21 CFR 50 and 56, clinical data for 510(k), De Novo, PMA
MDS – G20, MDS – REQ 2 and other international regulatory guidance.
Clinical Feasibility for New Product Development
- Clinical need and user-needs assessment
- Literature and competitor landscape review
- Clinician and user input summary
- Multi-market regulatory feasibility assessment (device classification, regulatory pathway and clinical evidence requirements)
- Identification of clinical and user requirements to inform product design inputs
- Formative and summative usability studies
- Clinical evidence roadmap with indicative costs and timelines
- Feasibility report with risks and go/no-go recommendation
- Support in preparation of clinical and regulatory documentation for applicable market submissions
Clinical Evaluation
- Clinical Evaluation Plan (CEP)
- Clinical evidence gap assessment and justification of available clinical data.
- Clinical literature search strategy, execution, screening and critical appraisal.
- State-of-the-art (SOTA) assessment and equivalence evaluation, where applicable.
- Clinical Evaluation Report (CER) with benefit-risk analysis.
- PMCF plan and PMCF evaluation report.
- SSCP and PSUR clinical inputs.
- Responses to Notified Body and regulatory authority queries.
Clinical Investigation/Trial Management
- Clinical investigation planning and study design
- Clinical study documentation
- Regulatory and Ethics Committee submissions
- Site management and study conduct
- Clinical monitoring and safety management
- Clinical data management and statistical support
- Study documentation, reporting and publication support
Proposed Service Offering Matrix
Our execution workflow is structured across four synchronized operational domains:
Strategy and Planning
Clinical evidence strategy; feasibility and site selection; evidence planning, study design, budget and timeline establishment; CIP, ICF, CRF, IB drafting, and clinical agreements.
Regulatory and Ethics
CDSCO clinical investigation permission (Form MD-22 / MD-23) submissions; ethics committee submissions; CTRI registration.
Study Conduct
Site initiation, monitoring, and close-out; investigator and vendor management; SAE and device deficiency reporting.
Evidence and Reporting
Clinical investigation reports; clinical evaluation report medical device (CER) and PMCF plans/reports; literature review and equivalence mapping.
What Sets Us Apart as a Medical Device Clinical services Provider
Specialized Clinical Expertise
Deep operational experience acting as a trusted medical device Clinical services for medical device manufacturers.
ISO 14155 Competency
Dedicated ISO 14155 consultant support ensuring flawless execution of clinical investigations and GCP compliance.
Regulatory Navigation
Expert handling of complex regulatory filings, including CDSCO clinical investigation permissions and Form MD-22 / MD-23 applications.
CER & PMCF Excellence
Specialized CER and PMCF consultant capabilities delivering inspection-ready clinical evaluation reports and post-market follow-up strategies.
Operon Strategist provides end-to-end clinical research solutions that bridge study design, regulatory approvals, and lifecycle clinical evaluation. By aligning clinical strategy with ISO 14155, CDSCO, and EU MDR standards, we ensure your medical devices achieve secure, audit-ready, and compliant market entry.
Frequently Asked Questions
What clinical services does Operon Strategist provide for medical devices?
We provide comprehensive clinical services including clinical investigation management, trial execution, clinical evaluations (CER/PMCF), and early-stage product feasibility studies.
How do you assist with CDSCO clinical investigation permission (Form MD-22 / MD-23)?
We manage complete regulatory submissions, draft required study documentation for any clinical investigation of a medical device, coordinate ethics committee reviews, and secure mandatory CDSCO approvals under Indian medical device rules.
What is the role of an ISO 14155 consultant in your clinical studies?
Our ISO 14155 consultants ensure that all pre-market and post-market clinical investigations are planned, conducted, recorded, and reported in strict compliance with Good Clinical Practice (GCP) for medical devices.
What deliverables are included in your clinical evaluation report (CER) services?
Our deliverables include Clinical Evaluation Plans (CEP), literature search protocols, SOTA assessments, comprehensive CERs with benefit-risk conclusions, and PMCF plans aligned with EU MDR clinical investigation requirements and global regulatory standards.