End-to-EndCompliance forlife sciences.From your first regulated product
to your global portfolio.

1. 01Phase

   Concept, Feasibility & Product Definition

   Define the opportunity, intended use, users, patients, and environment of use before the organization over-invests in development.

   • Unmet need and target population
   • Intended use and indications for use
   • User, patient, and use-environment profiles
   • Preliminary concept, claims, and benefit-risk hypothesis
2. 02Phase

   Regulatory Strategy

   Establish the pathway, evidence burden, submission strategy, and market sequencing before development and validation decisions are locked.

   • Product jurisdiction (device, IVD, drug, biologic, SaMD, combo)
   • Target markets, launch sequence, and classification
   • 510(k), De Novo, PMA, IDE, CE, IVDR, NDA, BLA pathways
   • Standards, predicate, claims, and regulator interaction plan
3. 03Phase

   Pre-Submission / Agency Engagement

   Use structured regulator, Notified Body, or Competent Authority interactions to reduce uncertainty around pathway, testing, endpoints, and claims.

   • FDA Q-Sub / Pre-Sub strategy and packages
   • Notified Body and Competent Authority engagement
   • IDE and clinical study feedback requests
   • Meeting execution, minutes, and feedback integration
4. 04Phase

   Quality System Foundation

   Build the controlled operating infrastructure to manage design, suppliers, documentation, training, risk, complaints, CAPA, and lifecycle change.

   • Document, record, training, and change control
   • Design controls, risk management, supplier qualification
   • Nonconforming product, complaints, vigilance, CAPA
   • Internal audit, management review, quality system governance
5. 05Phase

   Design & Development, Risk Management & Medical Device File

   Translate user needs, intended use, and risk controls into a controlled product design supported by Design & Development Files.

   • User needs, design inputs/outputs, and traceability
   • Risk analysis, controls, and benefit-risk evaluation
   • Verification, validation, usability, and human factors
   • Software lifecycle, cybersecurity, and specialty testing
6. 06Phase

   Clinical / Performance Evidence

   Generate and maintain the clinical, analytical, and performance evidence needed to support intended use, claims, safety, and benefit-risk.

   • Clinical evaluation strategy, plan, and literature review
   • Clinical investigations, IRB / ethics, monitoring, data
   • Analytical and clinical performance evidence (IVD)
   • Clinical / performance evaluation reports, PMCF and PMPF
7. 07Phase

   Technical Documentation

   Assemble and maintain the controlled body of evidence demonstrating conformity, safety, performance, risk control, and post-market readiness.

   • Product description, classification, conformity rationale
   • GSPR / essential principles and standards evidence
   • Risk, design, V&V, usability, software, cybersecurity
   • Clinical, manufacturing, labeling, PMS, and PMCF/PMPF
8. 08Phase

   Submission / Conformity Assessment / Authorization

   Submit the required regulatory or conformity package, manage review, respond to deficiencies, and obtain clearance, approval, or certification.

   • FDA 510(k), De Novo, PMA, IDE submissions
   • EU MDR / IVDR conformity assessment and NB review
   • Deficiency responses, labeling and claims alignment
   • Registration, listing, UDI, EUDAMED obligations
9. 09Phase

   Manufacturing, Supplier & Operational Readiness

   Prepare the company to consistently manufacture, inspect, release, distribute, support, and service the product under controlled conditions.

   • Supplier qualification, monitoring, and quality agreements
   • Process development, equipment qualification, validation
   • Packaging, labeling, storage, distribution, logistics
   • Medical Device File, release criteria, servicing readiness (QMSR / ISO 13485)
10. 10Phase

    Launch & Commercial Release

    Move from authorization to controlled market introduction with approved labeling, trained teams, release processes, and post-market systems live.

    • Final release authorization and product master data
    • Distribution, warehousing, inventory, and logistics
    • Sales, clinical, support, and field service training
    • Complaint intake, PMS and PMCF/PMPF activation
11. 11Phase

    Post-Market Surveillance, Vigilance, CAPA & Lifecycle

    Monitor real-world performance, detect signals, meet reporting obligations, update evidence, and continuously improve the product and Quality System.

    • PMS execution, complaint handling, investigations, trending
    • MDR, vigilance, serious incident and field safety reporting
    • CAPA, recalls, FSCAs, advisory notices, customer notifications
    • Periodic reports — PMS, PSUR, annual, jurisdictional
12. 12Phase

    Product Expansion, Sustaining Engineering & End-of-Life

    Manage changes, new indications, new markets, software updates, renewals, obsolescence, discontinuation, and post-discontinuation obligations.

    • New indications, claims, user groups, and markets
    • Software, hardware, material, supplier, and process changes
    • Regulatory impact assessments and change submissions
    • Obsolescence, discontinuation, and post-EOL monitoring

Each phase is connected within IntelaSolve^™ so artifacts, risks, and decisions flow naturally from concept to commercialization and beyond.