Services · Phase 6
Sustaining engineering and lifecycle management for launched products.
Address post-launch issues, design changes, complaints, cost reduction, and product improvements — without regressing on regulatory or quality posture.
When teams call us in
- A launched product is facing complaint trends, field issues, or yield problems.
- A cost-reduction effort is needed without regressing on regulatory or quality posture.
- A design change is being scoped and change-control logic across constituents needs to be crisp.
- Post-market surveillance signals are showing up in the risk file and remediation needs to be planned.
How we approach it
- Complaint and CAPA work driven by root-cause analysis, not band-aid fixes.
- Design changes scoped against design controls, risk management, regulatory, and manufacturing in parallel.
- Cost reduction tied to the design and the supply base, not isolated value-engineering exercises.
- Post-market data treated as design inputs, not just a quality reporting obligation.
Typical deliverables
- Complaint investigation and root-cause analysis.
- CAPA support and effectiveness verification.
- Design change scoping and change-control logic memo.
- Cost-reduction roadmap with regulatory and quality risk assessment.
- Post-market surveillance integration with the design and risk file.
- Field-issue remediation plans with named owners.
Frequently asked questions
- What kinds of products do you sustain?
- Launched medical devices and combination products — instruments, consumables, drug-delivery devices, and connected diagnostic platforms. Engagements typically focus on field-issue remediation, design changes, cost-reduction roadmaps, and post-market surveillance integration with the design and risk file.
- How do you handle CAPA effectiveness verification?
- CAPA effectiveness is structured against the original failure mode, the design and process change implemented, and the post-implementation evidence — not just procedural closure. We treat effectiveness verification as design controls work, not just quality reporting, so the change actually closes the underlying risk.
- Can you do cost reduction without regulatory rework?
- Often, yes — when the cost-reduction work is scoped against design controls, change-control logic, and the risk file in parallel. Cost reduction tied to the design and the supply base, with clear regulatory and quality risk assessment, can move without re-opening the submission. We refuse engagements that would treat cost reduction as a back-door redesign.
- Can you support post-market surveillance integration?
- Yes. Post-market data — complaints, field-service records, returns, surveillance — should feed back into the risk file and design history file as design inputs, not just be filed for the next audit. We help structure that loop so post-market signals actually drive product improvements.
Sustaining a launched product?
Engagements typically start with a scoping call to map the field-issue picture, change-control posture, and what good would look like.