White Paper

Expanding Your Pharmaceutical QMS for Combination Product Success

Free White Paper

Expanding Your Pharmaceutical QMS for Combination Product Success

Inside this White Paper

Pharmaceutical and biologics companies are rapidly moving into prefilled syringes, autoinjectors, on body injectors, and connected delivery systems, but most discover too late that their traditional drug based QMS cannot support device requirements. This whitepaper explains how to expand your existing cGMP framework to meet FDA’s 21 CFR Part 4, the new QMSR (ISO 13485:2016), and modern expectations for design controls, risk management, software, and cybersecurity.

Built on real world examples and actionable strategies, this guide shows you how to avoid costly delays, build a compliant device ready QMS, and accelerate successful combination product submissions.

Key Takaways

  • Combination products require more than a drug QMS. Device expectations now include design controls, purchasing controls, enhanced CAPA, risk management, and expanded management responsibility.
  • Only six new QMS elements are required under 21 CFR Part 4, but each expands significantly under the 2026 QMSR, mapping to full ISO 13485 clauses.
  • Design Controls are the top source of delays, especially missing EDDOs, weak verification data, or incomplete design history files.
  • Human Factors validation is essential, even when clinical trials perform well.
  • Connected or software enabled delivery systems trigger full IEC 62304 and cybersecurity documentation requirements, including SBOMs, threat modeling, penetration testing, and long term postmarket plans.
  • FDA expects device development to begin in Phase 2, not Phase 3, to prevent stability and verification gaps.
  • Real world failures are common, such as relying solely on syringe vendor data, missing device CAPAs, or excluding apps from regulatory submissions.
  • A device ready QMS can be built internally, through a hybrid consultant model, or fully outsourced depending on organizational resources and maturity.

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    Presenters

    Jessica Schafersman

    Subject Matter Expert, Design Controls

    Jessica Schafersman is a Biomedical Engineer, Project Management Professional, and Certified Usability Analyst, with more than 20 years of experience in medical product development, combination products, sterile implants, sterile disposables, capital equipment and instrumentation spanning Class I, II, and III... Read More

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