Lachman Consultants’ comprehensive list of services extend to all classes of medical devices and combination products including In Vitro Diagnostics, Integral, Cross-labeled and Kitted Combination Products.
The Lachman Ireland team helps clients ensure products are compliant with local and international regulatory requirements, such as Medical Device Regulation (MDR) in Europe, through a wide range of combination product consulting services. Our areas of consultation and support include medical products, SaMD, materials and components, processes and mechanical engineering, manufacturing, design history, as well as testing and validation.
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A wide range of consulting services for areas that include medical products, materials and components, processes and mechanical engineering and manufacturing.
- Harmonization of Drug/Biologic Device Development
- Data Integrity, Quality and Governance
- Quality Systems Audit
- Design History File Remediation
- Pre-Market Approval (PMA)
- Validation Review
- Preparation for Application
- Assessing Product Stability
- Many Others
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