Medical Device
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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Combination Products
A wide range of consulting services for areas that include medical products, materials and components, processes and mechanical engineering and manufacturing.
- Harmonisation of Drug/Biologic Device Development
- Quality Management System Assessments
- Data Integrity, Quality and Governance
- EU MDR Requirements
- CFR Part 4 Assessments
- Design History File Remediation
- Regulatory Citation Response and Remediation
- Pre-Market Approval (PMA)
- Validation Review
- Preparation for Application
- Assessing Product Stability
- ISO 13485 Support Services
- Many Others
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