Through a vast array of expertise and knowledge, we provide effective compliance and regulatory services for medical devices in areas such as cardiology, orthopedics and in vitro diagnostics, as well as combination devices like auto-injectors, pre-filled syringes and patch delivery systems.
In addition, Lachman also offers consultation and guidance for a wide range of other devices, including monitoring and measuring systems and Software as a Medical Device (SaMD).
The Lachman team has an outstanding record of client facilitation, which incorporates design history file building, quality systems audits and due diligence, full support in pre-application preparation, validation-specific review guidance and more.
Lachman Consultants provides insight, analysis and recommendations that include:
- General Audits
- FDA Response and Remediation
- FDA Pre-Approval
- FDA Inspection Support
- Due Diligence Reviews
- Medical Device Reporting
- Supplier Qualification
- EU MDR requirements
- ISO13485 Support Services
Multi-disciplinary groups of accomplished FDA and industry experts are assembled from Lachman’s Compliance, Regulatory, and Science and Technology Practice Groups. Each comprehensive team is selected and assigned on a project-specific basis, each according to your unique set of circumstances, needs and objectives.