REGULATORY COMPLIANCE SOLUTIONS

Medical Device Regulatory & Technical Data Services

Medical device and diagnostic development demands a uniquely specialized combination of clinical, engineering, and regulatory data expertise. Unlike pharmaceutical drug trials—governed primarily by ICH-GCP—device studies and product lifecycles operate under device-specific frameworks, including ISO 14155:2020, EU MDR 2017/745, and FDA 21 CFR Part 812. CPVIA provides dedicated, hands-on support across this entire data and compliance landscape.

From early-stage device classification and pre-submission regulatory strategy through post-market clinical follow-up (PMCF), our team brings deep expertise in FDA 510(k), PMA, De Novo, and EU MDR/IVDR pathways. We prepare comprehensive Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PER), SSCP documents, clinical investigation protocols, and specialized statistical analysis plans aligned with current global guidance.

CPVIA supports device developers and manufacturers across Class I, II, and III categories—spanning in vitro diagnostics (IVD), wearable sensors, smart telemetry, implantable devices, combination products, and Software as a Medical Device (SaMD).

"Our regulatory, engineering data, and clinical compliance experts bring hands-on experience across the full device submission lifecycle—ensuring your product development program meets the highest standards of objective evidence and data integrity."

FDA 510(k) / PMA EU MDR 2017/745 IVDR 2017/746 ISO 14155:2020 ISO 14971 Risk SaMD & IVDs

OUR SERVICES INCLUDE

Device Classification & Regulatory Pathway Strategy

Expert guidance on FDA class determination, 510(k) / PMA / De Novo pathway selection, EU MDR risk classification, and comprehensive global regulatory strategy from concept design through to submission.

Clinical Evaluation Report (CER & SSCP)

End-to-end CER and SSCP preparation aligned with MEDDEV 2.7.1 rev4 and EU MDR Annex XIV and XV—covering Clinical Evaluation Plans, systematic state-of-the-art reviews, data appraisal, and full clinical evaluation reporting.

Statistical Analysis Plans & Sample Size Modeling

Rigorous sample size calculations, customized statistical analysis plans, and clinical/technical performance study designs compliant with ISO 14155:2020 and ICH E9—from early feasibility to confirmatory pivotal studies.

Systematic Literature Review & Evidence Appraisal

Structured PICO-framework literature searches across PubMed, EMBASE, and Cochrane databases, featuring strict evidence appraisal, targeted data extraction, and clinical data gap analysis for device dossiers.

Risk Management Integration (ISO 14971)

Compilation and management of risk files, FMEA, fault tree analysis, and benefit-risk analysis documentation meeting ISO 14971:2019 requirements—seamlessly integrated with the technical file and clinical evaluation data.

FDA 510(k), PMA & De Novo Submission Support

Full submission support including predicate device analysis, substantial equivalence arguments, performance testing data reviews, clinical/technical data summaries, and active regulatory agency liaison.

EU MDR / IVDR Technical File Compilation

EU MDR 2017/745 and IVDR 2017/746 technical file compilation, Notified Body Q&A support, Annex IX / XI conformity assessment data orchestration, and CE marking documentation packages.

Post-Market Clinical Follow-up (PMCF) & Surveillance

PMCF plans and reports, Periodic Safety Update Reports (PSUR), vigilance and incident reporting data tracking, EUDAMED registration support, and real-world evidence (RWE) analysis for ongoing market compliance.

Clinical Investigation Protocols & Data Management

IDE-compliant clinical investigation protocol design, site data management oversight, GxP-compliant database setups, and validation programming for device pivotal and performance studies.

CDSCO India Regulatory Submissions

Medical Device Rules 2017 compliance, CDSCO Class A through D submissions, manufacturing/import license support, clinical investigation approval dossiers (Form MD-14), and specialized combination product guidance.

DEVICE LIFECYCLE

Support Across the Full Product Lifecycle

CPVIA provides comprehensive data, programming, and regulatory support at every stage—from first-in-human feasibility testing through post-market surveillance and continuous system compliance.

Early Development & Pre-Submission Strategy

Device classification, submission pathway determination, predicate device identification, risk-based evidence planning, and early engagement with FDA / Notified Bodies to plot the most robust pathway to market.

Pre-Market Dossier & Technical File Preparation

CER, PER, and SSCP preparation, clinical investigation protocol development, SAP authoring, systematic literature review, Notified Body Q&A support, and full technical dossier compilation.

Regulatory Submission Assembly & Liaison

Submission package finalization, eCTD / electronic dossier assembly, define.xml formatting where required, and ongoing regulatory agency liaison to rapidly respond to information requests.

Post-Market Surveillance & Ongoing Compliance

PMCF plans and reporting, PSUR compilation, vigilance data analysis, EUDAMED database registration, real-world evidence generation, and continuous lifecycle benefit-risk updates.

DEVICE CLASSIFICATIONS

We Support All Device Classes

From simple general controls to high-risk implantable systems and standalone software platforms—our regulatory, clinical, and data engineering teams are experienced across every classification tier.

CLASS I

Low Risk (General Controls)

Typically premarket exempt. CPVIA assists with technical documentation compilation, GMP / ISO 13485 quality management support, EU MDR Class I technical file preparation, and labeling/IFU compliance reviews.

CLASS II

Moderate Risk (Special Controls)

Typically requires 510(k) premarket notification in the US or CE marking under EU MDR. CPVIA provides full submission support, predicate device matching, substantial equivalence reporting, and performance testing data review.

CLASS III

High Risk (Stringent Controls)

Requires maximum evidence of safety and effectiveness, including PMA applications, IDE clinical investigations, and comprehensive CERs under EU MDR. We support statistical programming for pivotal studies, benefit-risk analysis, and post-market commitments.

GLOBAL REACH

Regulatory Submissions Across Major Markets

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United States — FDA Pathways

510(k) | PMA | De Novo | IDE Frameworks

510(k) premarket notification dossiers
PMA applications and panel review metrics
De Novo classification requests
IDE clinical investigation support & 21 CFR Part 812 compliance
Breakthrough Device Program strategy and data support

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European Union — MDR / IVDR

EU MDR 2017/745 | IVDR 2017/746 Technical Files

EU MDR technical file compilation and Notified Body support
IVDR 2017/746 performance evaluation reporting
CE marking conformity assessments (Annex IX / XI)
EUDAMED registration, SSCP, and PMCF documentation packages

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India — CDSCO Pathways

Medical Device Rules 2017 Compliance

CDSCO Class A, B, C, D submission support
Import, manufacturing license applications, and SUGAM portal registration
Clinical investigation approval dossiers (Form MD-14)
Combination product data mapping and classification guidance