Reinforce your team to uncover risks!
We help acquirers with Medical Device Technical Due Diligence
Our experience has helped top medical device companies make key acquisition decisions with independent 3rd party review. We fortify client teams to quickly discover technical and reliability problems, clinical trouble, and market adoption issues. And we aid clients’ understanding of the work required to fix issues or get products through regulatory approval. Engenious also helps R&D teams uncover negotiating points by providing unbiased, fact-based discovery of issues affecting client stakeholders.
Technical Due Diligence specifics where Engenious Design can help:
- DHF/DMR review
- Analog/digital circuit analysis and testing
- Mechanical design and mechanism analysis and testing
- Algorithm review and evaluation
- Embedded software design and testing
- Risk management review
- Regulatory analysis
- System testing of complex electromechanical systems
- System testing of unique metrology systems
- 60601 and collateral standard compliance review and testing
- Electrical/mechanical safety evaluation
- Review and replication of design verification, design validation
- FDA and ISO standard Human Factors/Usability Engineering review and evaluation
- In-clinic review of usability and reliability
- Expert clinician review of usability and fit within clinical workflows
- Labeling and Instructions for Use review
- Remediation of issues across all technical disciplines
- Supply chain risk assessment
- Manufacturing process review and risk assessment
- COGS analysis
- On-site interaction with the acquisition team or at contract manufacturers and key suppliers
Engenious Design's Technical Due Diligence capabilities
Our unstoppable team can tackle specific issues,
freeing your team for other strategic work
Reinforce your team to uncover risks!