Product Design & Development
Concept through detailed design for electromechanical, disposable and wearable medical devices.
Learn more →
Medical Device Engineering Consulting
Engineering medical devices that are safe, effective and ready for market.
PHC LOBER partners with medical device innovators to move from concept to production — with design controls, risk management and verification built into every step.
- ISO 13485 & FDA QMSR aligned
- ISO 14971 risk-based
- Concept to design transfer
What we do
End-to-end medical device engineering
Focused expertise across the product development lifecycle — engaged for a single deliverable or as an extension of your engineering team.
Design Controls & DHF
Traceable design history files built to FDA QMSR (21 CFR 820) and ISO 13485 expectations.
Learn more →Risk Management
ISO 14971 risk management files that drive design decisions, not just paperwork.
Learn more →Verification & Validation
Test strategy, protocols and reports that prove your device meets its requirements.
Learn more →Software & Electronics
Embedded systems and software lifecycle support aligned with IEC 62304.
Learn more →Design Transfer & Manufacturing
Bridge the gap between a validated design and repeatable, scalable production.
Learn more →
Why PHC LOBER
Engineering rigor with regulatory awareness built in
Medical device development is different. Every design decision has to be justified, traceable and safe. We bring an engineering-first mindset that keeps your documentation and your design moving forward together — so you're not reconstructing a DHF at the end of the project.
- Risk-driven design. Hazards are identified early and mitigated in the design, not the labeling.
- Traceability from day one. User needs, inputs, outputs and verification stay linked throughout.
- Right-sized process. Documentation that fits your device class and stage — not bureaucracy for its own sake.
- Flexible engagement. Project-based, milestone-based or embedded support.
Standards we work to
Our work is aligned with the recognized standards and regulations that medical device reviewers and auditors expect to see.
- ISO 13485
- FDA QMSR · 21 CFR 820
- ISO 14971
- IEC 60601-1
- IEC 62304
- IEC 62366-1
- ISO 10993
- ISO 11135 / 11137
How we work
A clear path from idea to production
Our engagements follow a structured, phase-gated process that mirrors the design control lifecycle.
Discover
Clarify clinical need, intended use, users and constraints.
Define
Translate needs into design inputs, a plan and an initial risk analysis.
Design
Develop, prototype and iterate with formal design reviews.
Verify & Validate
Generate objective evidence the device meets its requirements and user needs.
Transfer
Release a manufacturable design with a complete DMR and validated processes.
Who we help
Built for teams bringing devices to patients
Startups & founders
Turn a promising concept into a well-documented, testable design with a credible path to regulatory submission.
Growing manufacturers
Add specialized engineering capacity for new product programs or sustaining engineering without permanent headcount.
Established OEMs
Independent support for DHF remediation, risk file updates, V&V execution and design transfer projects.
Have a device concept or a design challenge?
Tell us where your project stands. We'll reply with practical next steps — no obligation.