Embedded Files
Three ways to work together, across four areas of focus.
Three ways to work together, across four areas of focus.
Embedded remediation lead: full-time inside your program, typically 6 to 12 months, for FDA 483 or warning-letter observations or a large backlog of design and risk files.
Fixed-scope deliverables: scoped and priced up front. A risk file or design and development file gap assessment, a hazard analysis or harms taxonomy, a QMSR gap assessment, procedures or training.
Advisory: a set block of hours each month for review of plans, files and submissions, and a senior sounding board before audits.
Risk management (ISO 14971:2019)
Risk management (ISO 14971:2019)
For: Manufacturers with large risk file portfolios, FDA observations on risk management, or AI/ML-enabled devices
What I Do:
Remediation of risk management files across large portfolios, prioritized by risk, with a worked "golden example" for each technology type before the volume work starts
Hazard analysis and harms taxonomy, including master harms list design
Benefit-risk analysis, and risk management for AI/ML-enabled devices and SaMD
Risk management training for engineering and quality teams
Background: Worldwide Risk Management Director, DePuy Synthes. Rewrote the C.R. Bard corporate risk management standard to align with ISO 14971 and FDA benefit-risk guidance. Listed committee member on ANSI/AAMI/ISO 14971:2019, AAMI/ISO TIR 24971:2020, AAMI CR34971:2022 and AAMI TIR34971:2023 (ISO 14971 applied to AI/ML).
Design and development
Design and development
For: Manufacturers with design and development file (DDF) gaps, design and development observations, or a backlog of design files to bring to standard
What I Do:
DDF gap assessment and remediation, with the risk management file kept in step with each DDF
Design and development remediation in response to FDA observations
Design review and design change, including for SaMD
Background: Took Pfizer's device DHFs from one approved document in two years to 74 DHF approvals in 24 months. Resolved a longstanding design control Form 483 observation within six months at Acclarent. Quality lead on 30+ FDA submissions through clearance, and participated in 30+ product launches. Listed committee member on AAMI TIR45:2023 (agile software).
Post-market into the risk file
Post-market into the risk file
For: Manufacturers whose complaint, clinical and post-market data are not reaching their risk files
What I Do:
Post-market surveillance plans, with review frequency set by device risk
Feeding complaints, clinical evaluation reports, PMCF and PSUR findings into the risk file
Complaint backlog assessment tied to a corrected hazard analysis
Background: Built, ran, oversaw at group level, and restarted post-market surveillance processes at Codman, Acclarent, DePuy Synthes and Bard. Assessed 3,000+ complaints in four months at Pfizer against a corrected hazard analysis. Listed committee member on AAMI/ISO TIR 20416:2020 (post-market surveillance).
QMS and QMSR
QMS and QMSR
For: Manufacturers bringing their QMS into line with the QMSR, and early-stage device companies building a QMS for the first time
What I Do:
QMSR gap assessment, with risk management integrated across the lifecycle
Right-sized QMS builds for early-stage device companies: design and development, risk management, document control, purchasing controls, and corrective and preventive action
Quality due diligence and post-acquisition QMS integration
Background: Established a startup QMS at CorMedica. Led full QMS remediations for devices and combination products at Pfizer, and at Cordis for a drug-eluting stent combination product, before 21 CFR Part 4 existed. Performed quality due diligence on acquisitions at Johnson & Johnson and C.R. Bard, and integrated acquired companies in neurovascular and cardiovascular. ISO 13485:2016 Lead Auditor (BSI).
Tell me what you're working on.
Tell me what you're working on.
FDA observations, a portfolio of risk files, a QMSR gap, or a first submission. I'll tell you plainly whether I'm the right fit.
Page updated
Report abuse