Embedded Files
Risk management and design control remediation for medical device and combination-product manufacturers.
Risk management and design control remediation for medical device and combination-product manufacturers.
I'm Hugo Felix. I bring 30+ years in device quality at Johnson & Johnson, C.R. Bard / BD, Siemens Healthcare Diagnostics and Pfizer. I'm a listed committee member on ISO 14971:2019 and on TIR 20416, the post-market surveillance guidance.
Where I help
Where I help
Risk management
Risk management
Risk file remediation at portfolio scale, hazard analysis and harms taxonomy, benefit-risk, and risk management for AI/ML-enabled devices.
Design and development
Design and development
Design and development file (DDF) gap assessment and remediation, risk management files included, plus design review and design change.
Post-market into the risk file
Post-market into the risk file
Making complaints, clinical evaluations and post-market surveillance data change the risk file, not just sit beside it.
Results
Results
Pfizer: one design history document approved in two years, then 74 DHF approvals in the following 24 months.
Pfizer: a 1,700-case complaint backlog, accumulated over 18 months, cleared in 3.
DePuy Synthes: oversaw rollout of a group Risk Management Policy and Master Harms List across five operating companies.
Bard Access Systems: zero observations in a combined EU MDR, ISO 13485 and MDSAP assessment. I represented design control.
100+ design history files, risk management files included, remediated or approved at DePuy Synthes and Pfizer.
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Tel. (877) 250-5022 | LinkedIn
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