Comprehensive Regulatory and Compliance Support for Global Device Manufacturers

Medical Device Consulting

Medical device companies face a dynamic and demanding regulatory environment, shaped by evolving technologies, global market expectations, and increasingly stringent standards. Lachman provides strategic and technical support across the full lifecycle of medical devices — from concept through commercialization — helping manufacturers meet FDA (QMSR), EU MDR, and ISO 13485 requirements with confidence.

Our multidisciplinary teams include experts formerly with Regulatory agencies and industry professionals with deep experience in cardiology, orthopedics, in vitro diagnostics (IVDs), combination products, and Software as a Medical Device (SaMD). Whether you’re preparing for market entry, responding to regulatory actions, or optimizing your quality systems, Lachman delivers tailored solutions that drive compliance and performance.

Medical Devices Consulting - Lachman Consultants

Who We Serve

  • Medical device manufacturers (Class I, II, III)
  • Combination product developers and manufacturers
  • SaMD and connected device companies
  • IVD and diagnostic technology firms
  • Contract manufacturers and design firms
  • Global device companies entering US, EU, or other global markets

How Lachman Supports Medical Device Clients

Lachman Consultants offers end-to-end support for medical device regulatory and compliance needs. Our project-specific teams integrate expertise from our Compliance, Regulatory, and Science & Technology Practice Groups to deliver targeted, effective solutions.

We help clients:

  • Prepare regulatory submissions (510(k), PMA, De Novo, CE Marking)
  • Build and audit quality systems aligned with ISO 13485 and FDA QSR, QMSR
  • Conduct due diligence and supplier qualification assessments
  • Develop and maintain design history files (DHF) and technical documentation
  • Respond to FDA, EU, and other global regulatory actions with strategic remediation plans
  • Validate software and SaMD platforms under applicable standards
  • Train teams on device-specific GMP, MDR, and inspection protocols

Key Challenges in the Medical Device Sector

  • Navigating FDA pathways (510(k), PMA, De Novo, IDE, HDE)
  • Meeting EU MDR 2017/745 requirements and CE marking standards
  • Building and maintaining QMSR and ISO 13485-compliant quality systems
  • Managing design history files, technical documentation, and risk files
  • Ensuring readiness for FDA and Notified Body inspections
  • Addressing post-market surveillance, vigilance, and reporting obligations
  • Responding to FDA 483s, Warning Letters, and EU non-conformities

Medical Device Regulatory Consulting - Lachman Consultants