Services · Phase 4
Regulatory, quality, and design controls — connected to the rest of development.
Connect requirements, risks, verification, validation, usability, and regulatory evidence into a coherent design controls package — aligned to FDA 21 CFR 820 / Part 4, ISO 13485, ISO 14971, and IEC 62366.
When teams call us in
- A program is approaching design freeze and the design history file isn't in shape for an FDA inspection.
- A drug-device combination product needs a coherent regulatory strategy under 21 CFR Part 4 — not two disconnected Part 820 / Part 211 workstreams.
- A change is coming and the team needs change-decision logic that will hold up against 510(k) precedent.
- Risk-management and design-controls artifacts have drifted apart and the next audit is on the calendar.
How we approach it
- Map the regulatory surface area first — primary mode of action, predicate strategy, applicable standards, and the cause-and-effect chain back to user needs.
- Treat ISO 14971 risk management as the architectural backbone of the QMS, not a parallel deliverable.
- Build verification and validation evidence so traceability from user needs → design inputs → design outputs → V&V is auditable end-to-end.
- Coordinate with regulatory counsel on submission strategy and with quality on inspection readiness.
Typical deliverables
- Design History File rebuild or remediation plan.
- Risk Management File aligned to ISO 14971:2019 — hazard analysis, risk-control traceability, and post-production input.
- Design controls procedure suite scoped to QSR / ISO 13485 expectations.
- 510(k) change-decision logic memo and supporting evidence.
- 21 CFR Part 4 mapping and combination-product gap analysis.
- Submission-support engineering evidence package and FDA inspection readiness assessment.
Frequently asked questions
- Which standards do you work under?
- FDA 21 CFR Part 820 (QSR), 21 CFR Part 4 for combination products, ISO 13485 for medical-device QMS, ISO 14971 for risk management, and IEC 62366 for usability engineering. We also work fluently with the design controls and risk management linkages between them.
- How do design controls integrate with combination products?
- 21 CFR Part 4 lets a combination product comply with either the device QSR (Part 820) plus specified drug CGMP requirements (Part 211), or vice versa, under a streamlined approach. Getting the integration of device design controls and drug CGMP right is the single biggest determinant of audit and submission readiness — and the place combination-product programs most often stall.
- Can you support FDA submissions or pre-submission interactions?
- We support submission strategy and the engineering and design-controls evidence behind it — change-decision logic, risk justifications, design history file structure, and verification/validation traceability. We work alongside the firm's regulatory submissions counsel rather than replacing it.
- What does an engagement look like?
- Most engagements start with a scoping call to map the question, the stakeholders, and the regulatory surface area. Typical engagements run from a focused two-week assessment to a multi-quarter embedded engagement spanning design freeze, V&V, and submission support.
Approaching design freeze, V&V, or submission?
Engagements typically start with a scoping call to map the regulatory surface area and the timeline you are working toward.