Medical Devices & Combo Products

Every Lachman Consultants client who receives services and support for their Medical Devices experiences excellence at the highest levels of quality and satisfaction.

Experience excellence in technical, regulatory consultation, and guidance services for medical devices and combination products.

CONSULTATION, SERVICES & SUPPORT FROM A TRUSTED PARTNER

Every Lachman Consultants client who receives services and support for their Medical Devices experiences excellence at the highest levels of quality and satisfaction. 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 invitro diagnostics as well as combination devices like auto-injectors, patch delivery systems, and pre-filled syringes. 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 Medical Devices Services and Features:

  • 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.

Lachman Consultant Services, Inc. (Lachman Consultants) offers a wide range of consulting services for areas that include medical products, SaMD, materials and components, processes and mechanical engineering and manufacturing, as well as testing and validation. Our team of experts provides consultative services for combination products such as auto injectors, pre-filled syringes, patch delivery systems, and many others.

Lachman Consultants supports clients with compliance guidance that includes due diligence review, general auditing, quality assessment remediation work for 483 or warning letters, as well as design history file building and documentation. We offer a full menu of regulatory services that includes traditional 510k, de novo filing under 510k, and Premarket Approvals.

Lachman Consultants Combination Products Services and Features:

  • Harmonization of Drug/Biologic – Device Development
  • Due Diligence Assessments
  • Quality Systems Audit to 21CFR Part 4
  • Quality Assessment Remediation Work for 483 or Warning Letters
  • Design History File Remediation
  • 510k Submissions
  • Assistance on NDA/BLA submissions
  • Premarket Approval (PMA)
  • Validation Review
  • Preparation for Application
  • FDA-Related Services
  • Develop and Enhance Laboratory Controls
  • Optimize Product Formulation and Processes
  • Assess Product Stability